Fremanezumab for the Prevention of Menstrually-related Migraine Attacks - a Prospective, Observational Study According to Routine Neurological Care in Switzerland

The goal of this observational study is to compare, in real-world clinical practice, the effect of fremanezumab on menstrual migraine to the effect of fremanezumab on non-perimenstrual attacks. The main question it aims to answer is, if menstrually-related migraine attacks respond equally well to anti-CGRP mAb treatment with fremanezumab as non-menstrually-related attacks.
Participants diagnosed with episodic or chronic migraine with menstrually-related migraine with or without aura and treated with fremanzumab according to the SmPC will be required to maintain a headache diary over at least 3 months prior to and 6 months after fremanezumab initiation.

Start Date09 Apr 2024

Sponsor / Collaborator

Insel Gruppe AG

NCT06173661 / RecruitingPhase 4IIT

A Single Center, Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Fremanezumab (675 mg Quarterly) in Female Patients Aged 18-45 With Menstrual Migraine

The goal of this clinical trial is to learn about how a migraine prevention medicine works for people who have migraines/headaches with their menstrual period. The study includes people ages 18 to 45 who have been diagnosed with migraine and who have a migraine with their menstrual period or those who have migraines with their menstrual period and at other times of the month as well.
The main question the study aims to answer are:
• Does fremanazemab, an injectable calcitonin gene-related peptide (CGRP) pathway targeting therapy, decrease migraines associated with menstruation?
Participants will
have an evaluation and examination by a headache specialist physician
will receive the study medicine or inactive substitute every three months for two treatments
fill out diaries about their migraines
have tests on saliva to measure hormone levels
Researchers will compare the people who get the medicine to those who get the inactive substitute to see if there are differences in response.

Start Date01 Mar 2024

Sponsor / Collaborator

The Brigham & Women's Hospital, Inc.

[+1]

CTIS2022-503167-15-00 / RecruitingIIT

The effect of fremanezumab on pain in patients with Complex Regional Pain Syndrome: a randomized, double-blind, proof of concept, placebo-controlled trial

Start Date11 Dec 2023

Sponsor / Collaborator

Århus Universitetshospital

100 Clinical Results associated with Fremanezumab-VFRM

100 Translational Medicine associated with Fremanezumab-VFRM

100 Patents (Medical) associated with Fremanezumab-VFRM

558

Literatures (Medical) associated with Fremanezumab-VFRM

01 Feb 2025·Neurology-Clinical Practice

Efficacy and Tolerability of Anti-CGRP Monoclonal Antibodies in Patients Aged ≥ 65 Years With Daily or Nondaily Migraine

Article

Author: Ahmed, Zubair ; Hennessy, Elise ; Mays, Maryann ; Sonneborn, Claire ; Suneja, Aarushi ; Hogue, Olivia ; Salim, Amira ; Biswas, Sudipa ; Mata, Ignacio F.

Background and Objectives:

Despite decreasing prevalence of migraine with advancing age, there remains a significant proportion of individuals aged ≥65 years with migraine. Treatment of this population is difficult and they are often excluded from clinical trials, limiting evidence regarding migraine treatment outcomes. Our objective is to assess the efficacy and tolerability of anti-calcitonin gene-related peptide (CGRP) monoclonal antibody (mAb) therapies (erenumab, fremanezumab, and galcanezumab) in patients ≥65 years (O65) compared with patients <65 (U65) with daily or nondaily migraine.

Methods:

This observational study uses retrospective data from the electronic medical records of patients who were treated with an anti-CGRP mAb between June 2018 and November 2021. Efficacy was determined through a reduction in monthly migraine days (MMDs) and Headache Impact Test (HIT-6) scores from baseline to posttreatment. Tolerability was examined through the number of adverse events reported per group. Mann-Whitney tests were used to compare the efficacy and tolerability of U65 and O65 patients overall and separated into daily and nondaily migraine groups.

Results:

The dataset consisted of U65 (n = 2,707; median [interquartile range]; 45.4 [35.8-53.8] years) or O65 (n = 304; 69.5 [67.3-73.3] years) and further separated into daily (n = 1,303) and nondaily (n = 1,708) migraine. There was no difference (p = 0.57) in the median MMD reduction between U65 (10 days [0.0-17.0]) and O65 (10 days [0.0-16.5]). Similarly, no difference was found among patients with nondaily migraine (p = 0.82) and patients with daily migraine (p = 0.59). HIT-6 scores decreased from severe to moderate/substantial impact for all groups. The daily and nondaily groups showed differences in meeting the 50% improvement threshold (nondaily U65, 67% vs daily U65, 54%, p < 0.0001; nondaily O65, 65% vs daily O65, 49%, p = 0.008). Side effects were reported (829/3,011), with a higher incidence in the U65 (22% O65, 28% U65). The most common side effects for both groups were injection site reaction/rash (40%) and constipation (25%).

Discussion:

This retrospective analysis provides real-world evidence that there is no difference in the efficacy and tolerability of treatment with erenumab, fremanezumab, and galcanezumab in patients O65 when compared with patients U65 both with daily or nondaily migraine. These data may help guide the choice of migraine treatment in older populations.

01 Nov 2024·NEUROLOGICAL SCIENCES

Blood pressure monitoring in elderly migraineurs starting an anti-CGRP monoclonal antibody: a real-world prospective study

Article

Author: Andrini, Giorgia ; Mascarella, Davide ; Favoni, Valentina ; Vernieri, Fabrizio ; Guerzoni, Simona ; Cevoli, Sabina ; Pierangeli, Giulia ; Altamura, Claudia ; Baraldi, Carlo ; Lo Castro, Flavia

Abstract:

Background:

While monoclonal antibodies (mAbs) targeting the CGRP pathway have revolutionized migraine management due to their improved tolerance and adherence, concerns remain about their potential impact on blood pressure (BP), especially in older patients, due to CGRP-mediated vasodilation blockade. Given the growing use of these therapies in older populations, assessing their cardiovascular (CV) safety is of paramount importance.

Methods:

This multicentric observational prospective study focused on migraine sufferers aged ≥ 60 who began erenumab, galcanezumab, or fremanezumab for prevention. Baseline, three-month, and twelve-month BP measurements were collected. Changes in antihypertensive medication and "Newly or Worsened Hypertensive" patients (NWHP) were assessed.

Results:

Among 155 patients receiving anti-CGRP mAbs (40 Erenumab, 47 Galcanezumab, 68 Fremanezumab), 42.5% had hypertension history and 39% were on antihypertensive treatment. No significant systolic or diastolic BP changes occurred at any time point compared to baseline (all p > 0.05), with no differences between the three groups. After one year, 20/155 (12.9%) patients were considered NWHP; 11/20 had prior hypertension, and 5/11 adjusted antihypertensive therapy. Among 9/20 newly hypertensive patients, 5/9 had a single measurement above the normal threshold with no requirement for new pharmacological therapy. A higher baseline BP value was associated with increased BP (p = 0.002).

Conclusions:

The study concludes that treatment with anti-CGRP mAbs over one year does not significantly affect BP in patients aged ≥ 60, nor does it increase the incidence of hypertension compared to general population trends. Nonetheless, continuous monitoring and further long-term studies are necessary to fullya scertain the cardiovascular safety of these medications in the elderly.

01 Nov 2024·Expert Review of Neurotherapeutics

Menopause and its impact on the effectiveness of fremanezumab for migraine prophylaxis: post-hoc analysis of a prospective, real-world Greek registry.

Article

Author: Rikos, Dimitrios ; Vikelis, Michail ; Rallis, Dimitrios ; Argyriou, Andreas A ; Soldatos, Panagiotis ; Litsardopoulos, Pantelis ; Xiromerisiou, Georgia ; Dermitzakis, Emmanouil V ; Andreou, Anna P

OBJECTIVE:

This post-hoc analysis of data extracted from a prospective study aimed to explore for the first time if the efficacy of fremanezumab in preventing difficult-to-treat migraine, according to ICHD-III, would differ between pre-menopausal and post-menopausal women.

METHODS:

A total of 171 (aged 18-70 years) fremanezumab-treated female migraine patients for six consecutive months were classified to those at pre-menopausal (n = 82) or post-menopausal (n = 89). Monthly headache days (MHD), disability, and quality of life (QOL) outcomes were assessed at baseline and at week 24 post-fremanezumab within subgroups and were then compared between them. Safety and tolerability were also assessed.

RESULTS:

In both groups, fremanezumab demonstrated significant reductions in MHDs, reduced disability, and higher QOL scores at week 24 post-treatment, compared to baseline. However, the between-subgroup comparison documented that pre-menopausal women and those at post-menopausal comparably benefited with significant reductions in overall MHDs (p = 0.883). Less disability, according to MIDAS (p = 0.696) and HIT-6 scores (p = 0.912), as well as higher QOL scores at week 24 post-fremanezumab, were also comparably evident in both groups. Safety was excellent across both subgroups.

CONCLUSION:

Fremanezumab can be considered a very effective treatment option for preventing migraines in difficult-to-treat women, aged 18-70 years, regardless of their menopausal status.

News (Medical) associated with Fremanezumab-VFRM

10 Oct 2024

·www.globenewswire.com

Teva Prolia® (Denosumab) Biosimilar Candidate is Accepted for Review by U.S. FDA and EU EMA

Prolia® (denosumab) is indicated to treat certain conditions that lead to high risk for fracture, including osteoporosis in postmenopausal women TVB-009P, Teva’s proposed biosimilar to Prolia, showed Phase 3 clinical results in osteoporosis and is part of Teva’s robust biosimilar portfolio – 7 approved biosimilars and 16 in the pipeline – across critical therapeutic areas such as oncology, immunology and respiratory medicine Anticipated decision by both agencies is expected in 2H 2025 Oct. 08, 2024 -- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the United States (U.S.) Food and Drug Administration (FDA) has accepted, and the European Medicines Agency (EMA) has validated, applications for TVB-009P, a biosimilar candidate to Prolia® (denosumab).1 Both applications, a Biologics License Application (BLA) in the U.S., seeking interchangeability, and a Marketing Authorization Application (MAA) in the European Union (EU), include all indications approved for the reference product, Prolia, including conditions with a high risk for fracture, such as osteoporosis in postmenopausal women. The FDA’s anticipated decision and EMA’s expected opinion are anticipated in the second half of 2025. TVB-009P, Teva’s proposed biosimilar to Prolia, is the first of Teva’s internally developed biosimilars to be submitted to the U.S. FDA. The submissions are supported by a comprehensive analytical and clinical data package including results from the randomized, double-blind TVB009-IMB-30085 Phase 3 trial investigating the safety and efficacy of TVB-009P versus Prolia in women with postmenopausal osteoporosis.2 The submissions also include data from the TVB009-BE-10157 pharmacokinetics and pharmacodynamics study in healthy volunteers, which demonstrated pharmacokinetic similarity to the reference product.3 With over 120 years of experience in providing accessible and affordable medicines, Teva is one of the leaders in the biosimilar market with over 20 biosimilars in our portfolio and pipeline. “The filing acceptance and validation of TVB-009P, our proposed biosimilar to Prolia, underscores Teva’s commitment to broadening global access to biosimilars in both regions,” said Steffen Nock, PhD, Head of Biosimilars and Chief Scientific Officer at Teva. “We are leveraging our strong background in generics and our successful track record with biologics, such as AJOVY®, to drive growth in the biosimilars market. Our goal is to expand our strategic partnerships and enhance our portfolio, ultimately offering more affordable treatment options for patients.” Throughout the U.S. and Europe, over 165 million women are either in menopause or postmenopause.4-6 Hormonal changes during menopause place women at a higher risk for osteoporosis, which affects about 25% of older women in the U.S. and the EU.5-10 Osteoporosis increases the risk of bone fractures, and an estimated one in three women over the age of 50 will suffer a fracture due to this condition.11 Osteoporosis is a disease associated with low bone density as the bones lose the ability to reform and regrow themselves as we age.12 As of 2023, about 15 million women over the age of 50 had osteoporosis in the United States.5,9 In Europe, about 32 million people have osteoporosis, with 25.5 million estimated to be women.13 Of these European women, 14 million went untreated in 2019 despite being eligible.14 TVB-009P is a monoclonal antibody and a biosimilar candidate to Prolia® (denosumab). Denosumab targets RANKL (receptor activator of nuclear factor kappa-B ligand), a key protein involved in the regulation of bone metabolism and osteoclast formation. TVB-009P is an investigational product and has not received regulatory approval in any country. Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global pharmaceutical leader with a category-defying portfolio, harnessing our generics expertise and stepping up innovation to continue the momentum behind the discovery, delivery, and expanded development of modern medicine. For over 120 years, Teva's commitment to bettering health has never wavered. Today, the company’s global network of capabilities enables its ~37,000 employees across 58 markets to push the boundaries of scientific innovation and deliver quality medicines to help improve health outcomes of millions of patients every day. To learn more about how Teva is all in for better health, visit www.tevapharm.com. Teva Pharmaceuticals, Inc. (2024). A Study to Test if TVB-009P is Effective in Relieving Postmenopausal Osteoporosis. ClinicalTrials.gov. https://clinicaltrials.gov/study/NCT04729621. Accessed October 3, 2024. Data on File. Clinical Study report: Phase I Study TVB009-BE-10157. A Randomized, Double-Blind, Single-Dose, Parallel-Group Study to Investigate the Pharmacokinetic and Pharmacodynamic Similarity of TVB-009 Versus Denosumab (Prolia®) in Healthy Subjects Phase 1Study TVB009-BE-10157. Teva Pharmaceuticals. Palacios, S., et al. (2010). Age of menopause and impact of climacteric symptoms by geographical region. Climacteric, 13(5), 419–428. https://doi-org.libproxy1.nus.edu.sg/10.3109/13697137.2010.507886. Accessed October 3, 2024. U.S. Census Bureau. (2022). Age and Sex. American Community Survey, ACS 1 -Year Estimates Subject Tables, Table S0101, 2022. https://data.census.gov/table/ACSST1Y2022.S0101?t=Age and Sex. Accessed October 3, 2024. Eurostat. (2024). Population on 1 January by Age and Sex. https://ec.europa.eu/eurostat/databrowser/view/demo_pjan__custom_12638069/default/bar?lang=en. Accessed on October 3, 2024. Riggs, B.L. (2000). The mechanisms of estrogen regulation of bone resorption. J Clin Invest, 106(10):1203-4. https://www-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/pmc/articles/PMC381441/. Accessed October 3, 2024. Salari, N., et al. (2021). Global prevalence of osteoporosis among the world older adults: a comprehensive systematic review and meta-analysis. J Orthop Surg Res, 16(1), 669. https://doi-org.libproxy1.nus.edu.sg/10.1186/s13018-021-02821-8. Accessed October 3, 2024. Walker, M.D., et al. (2023). Postmenopausal osteoporosis. NEJM, 389(21), 1979–1991. https://doi-org.libproxy1.nus.edu.sg/10.1056/nejmcp2307353. Accessed October 3, 2024. Kanis, J.A., et al. (2021). SCOPE 2021: A New Scorecard for Osteoporosis in Europe. Arch Osteoporos, 16(1):82. Lorentzon M., et al. (2022). Osteoporosis and fractures in women: the burden of disease. Climacteric, (1):4-10. https://pubmed-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/34319208/. Accessed October 3, 2024. What are osteoporosis warning signs? (2024). Cleveland Clinic. https://my.clevelandclinic.org/health/diseases/4443-osteoporosis. Accessed October 3, 2024. Key Statistic for Europe: International Osteoporosis Foundation. (n.d.). https://www.osteoporosis.foundation/facts-statistics/key-statistic-for-europe. Accessed October 3, 2024. Willers C., et al. (2022). SCOPE review panel of the IOF. Osteoporosis in Europe: a compendium of country-specific reports. Arch Osteoporos, 17(1):23. https://pubmed-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/35079919/. Accessed October 3, 2024. The content above comes from the network. if any infringement, please contact us to modify.

Clinical ResultDrug Approval

09 Oct 2024

·pipelinereview.com

Teva Prolia® (Denosumab) Biosimilar Candidate is Accepted for Review by U.S. FDA and EU EMAProlia® (denosumab) is indicated to treat certain conditions that lead to high risk for

TEL AVIV, Israel I October 08, 2024 I Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the United States (U.S.) Food and Drug Administration (FDA) has accepted, and the European Medicines Agency (EMA) has validated, applications for TVB-009P, a biosimilar candidate to Prolia ® (denosumab). 1 Both applications, a Biologics License Application (BLA) in the U.S., seeking interchangeability, and a Marketing Authorization Application (MAA) in the European Union (EU), include all indications approved for the reference product, Prolia, including conditions with a high risk for fracture, such as osteoporosis in postmenopausal women. The FDA’s anticipated decision and EMA’s expected opinion are anticipated in the second half of 2025. TVB-009P, Teva’s proposed biosimilar to Prolia, is the first of Teva’s internally developed biosimilars to be submitted to the U.S. FDA. The submissions are supported by a comprehensive analytical and clinical data package including results from the randomized, double-blind TVB009-IMB-30085 Phase 3 trial investigating the safety and efficacy of TVB-009P versus Prolia in women with postmenopausal osteoporosis. 2 The submissions also include data from the TVB009-BE-10157 pharmacokinetics and pharmacodynamics study in healthy volunteers, which demonstrated pharmacokinetic similarity to the reference product. 3 With over 120 years of experience in providing accessible and affordable medicines, Teva is one of the leaders in the biosimilar market with over 20 biosimilars in our portfolio and pipeline. “The filing acceptance and validation of TVB-009P, our proposed biosimilar to Prolia, underscores Teva’s commitment to broadening global access to biosimilars in both regions,” said Steffen Nock, PhD, Head of Biosimilars and Chief Scientific Officer at Teva. “We are leveraging our strong background in generics and our successful track record with biologics, such as AJOVY ® , to drive growth in the biosimilars market. Our goal is to expand our strategic partnerships and enhance our portfolio, ultimately offering more affordable treatment options for patients.” Throughout the U.S. and Europe, over 165 million women are either in menopause or postmenopause. 4-6 Hormonal changes during menopause place women at a higher risk for osteoporosis, which affects about 25% of older women in the U.S. and the EU. 5-10 Osteoporosis increases the risk of bone fractures, and an estimated one in three women over the age of 50 will suffer a fracture due to this condition. 11 About Osteoporosis Osteoporosis is a disease associated with low bone density as the bones lose the ability to reform and regrow themselves as we age. 12 As of 2023, about 15 million women over the age of 50 had osteoporosis in the United States. 5,9 In Europe, about 32 million people have osteoporosis, with 25.5 million estimated to be women. 13 Of these European women, 14 million went untreated in 2019 despite being eligible. 14 About TVB-009P (denosumab) TVB-009P is a monoclonal antibody and a biosimilar candidate to Prolia ® (denosumab). Denosumab targets RANKL (receptor activator of nuclear factor kappa-B ligand), a key protein involved in the regulation of bone metabolism and osteoclast formation. TVB-009P is an investigational product and has not received regulatory approval in any country. About Teva Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global pharmaceutical leader with a category-defying portfolio, harnessing our generics expertise and stepping up innovation to continue the momentum behind the discovery, delivery, and expanded development of modern medicine. For over 120 years, Teva’s commitment to bettering health has never wavered. Today, the company’s global network of capabilities enables its ~37,000 employees across 58 markets to push the boundaries of scientific innovation and deliver quality medicines to help improve health outcomes of millions of patients every day. To learn more about how Teva is all in for better health, visit www.tevapharm.com . SOURCE: Teva Pharmaceutical Industries

Clinical ResultPhase 3NDADrug Approval

08 Oct 2024

·www.tevapharm.com

Teva Prolia® (Denosumab) Biosimilar Candidate is Accepted for Review by U.S. FDA and EU EMA

Prolia® (denosumab) is indicated to treat certain conditions that lead to high risk for fracture, including osteoporosis in postmenopausal women TVB-009P, Teva’s proposed biosimilar to Prolia, showed Phase 3 clinical results in osteoporosis and is part of Teva’s robust biosimilar portfolio – 7 approved biosimilars and 16 in the pipeline – across critical therapeutic areas such as oncology, immunology and respiratory medicine Anticipated decision by both agencies is expected in 2H 2025 TEL AVIV, Israel, Oct. 08, 2024 (GLOBE NEWSWIRE) -- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the United States (U.S.) Food and Drug Administration (FDA) has accepted, and the European Medicines Agency (EMA) has validated, applications for TVB-009P, a biosimilar candidate to Prolia® (denosumab).1 Both applications, a Biologics License Application (BLA) in the U.S., seeking interchangeability, and a Marketing Authorization Application (MAA) in the European Union (EU), include all indications approved for the reference product, Prolia, including conditions with a high risk for fracture, such as osteoporosis in postmenopausal women. The FDA’s anticipated decision and EMA’s expected opinion are anticipated in the second half of 2025. TVB-009P, Teva’s proposed biosimilar to Prolia, is the first of Teva’s internally developed biosimilars to be submitted to the U.S. FDA. The submissions are supported by a comprehensive analytical and clinical data package including results from the randomized, double-blind TVB009-IMB-30085 Phase 3 trial investigating the safety and efficacy of TVB-009P versus Prolia in women with postmenopausal osteoporosis.2 The submissions also include data from the TVB009-BE-10157 pharmacokinetics and pharmacodynamics study in healthy volunteers, which demonstrated pharmacokinetic similarity to the reference product.3 With over 120 years of experience in providing accessible and affordable medicines, Teva is one of the leaders in the biosimilar market with over 20 biosimilars in our portfolio and pipeline. “The filing acceptance and validation of TVB-009P, our proposed biosimilar to Prolia, underscores Teva’s commitment to broadening global access to biosimilars in both regions,” said Steffen Nock, PhD, Head of Biosimilars and Chief Scientific Officer at Teva. “We are leveraging our strong background in generics and our successful track record with biologics, such as AJOVY®, to drive growth in the biosimilars market. Our goal is to expand our strategic partnerships and enhance our portfolio, ultimately offering more affordable treatment options for patients.” Throughout the U.S. and Europe, over 165 million women are either in menopause or postmenopause.4-6 Hormonal changes during menopause place women at a higher risk for osteoporosis, which affects about 25% of older women in the U.S. and the EU.5-10 Osteoporosis increases the risk of bone fractures, and an estimated one in three women over the age of 50 will suffer a fracture due to this condition.11 About OsteoporosisOsteoporosis is a disease associated with low bone density as the bones lose the ability to reform and regrow themselves as we age.12 As of 2023, about 15 million women over the age of 50 had osteoporosis in the United States.5,9 In Europe, about 32 million people have osteoporosis, with 25.5 million estimated to be women.13 Of these European women, 14 million went untreated in 2019 despite being eligible.14 About TVB-009P (denosumab)TVB-009P is a monoclonal antibody and a biosimilar candidate to Prolia® (denosumab). Denosumab targets RANKL (receptor activator of nuclear factor kappa-B ligand), a key protein involved in the regulation of bone metabolism and osteoclast formation. TVB-009P is an investigational product and has not received regulatory approval in any country. About TevaTeva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global pharmaceutical leader with a category-defying portfolio, harnessing our generics expertise and stepping up innovation to continue the momentum behind the discovery, delivery, and expanded development of modern medicine. For over 120 years, Teva's commitment to bettering health has never wavered. Today, the company’s global network of capabilities enables its ~37,000 employees across 58 markets to push the boundaries of scientific innovation and deliver quality medicines to help improve health outcomes of millions of patients every day. To learn more about how Teva is all in for better health, visit www.tevapharm.com. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully develop TVB-009P, a proposed biosimilar to Prolia® (denosumab); risks that regulatory approvals and other requirements may delay the development and commercialization of our biosimilars; our ability to successfully launch and execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development; and other factors discussed in this press release, in our Quarterly Report for the second quarter of 2024, and in our Annual Report on Form 10-K for the year ended December 31, 2023, including in the sections captioned “Risk Factors.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements. ______________________ Prolia® is a registered trademark of Amgen, Inc. Teva Pharmaceuticals, Inc. (2024). A Study to Test if TVB-009P is Effective in Relieving Postmenopausal Osteoporosis. ClinicalTrials.gov. https://clinicaltrials.gov/study/NCT04729621. Accessed October 3, 2024. Data on File. Clinical Study report: Phase I Study TVB009-BE-10157. A Randomized, Double-Blind, Single-Dose, Parallel-Group Study to Investigate the Pharmacokinetic and Pharmacodynamic Similarity of TVB-009 Versus Denosumab (Prolia®) in Healthy Subjects Phase 1Study TVB009-BE-10157. Teva Pharmaceuticals. Palacios, S., et al. (2010). Age of menopause and impact of climacteric symptoms by geographical region. Climacteric, 13(5), 419–428. https://doi-org.libproxy1.nus.edu.sg/10.3109/13697137.2010.507886. Accessed October 3, 2024. U.S. Census Bureau. (2022). Age and Sex. American Community Survey, ACS 1 -Year Estimates Subject Tables, Table S0101, 2022.https://data.census.gov/table/ACSST1Y2022.S0101?t=Age and Sex. Accessed October 3, 2024. Eurostat. (2024). Population on 1 January by Age and Sex. https://ec.europa.eu/eurostat/databrowser/view/demo_pjan__custom_12638069/default/bar?lang=en. Accessed on October 3, 2024. Riggs, B.L. (2000). The mechanisms of estrogen regulation of bone resorption. J Clin Invest, 106(10):1203-4. https://www-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/pmc/articles/PMC381441/. Accessed October 3, 2024. Salari, N., et al. (2021). Global prevalence of osteoporosis among the world older adults: a comprehensive systematic review and meta-analysis. J Orthop Surg Res, 16(1), 669. https://doi-org.libproxy1.nus.edu.sg/10.1186/s13018-021-02821-8. Accessed October 3, 2024. Walker, M.D., et al. (2023). Postmenopausal osteoporosis. NEJM, 389(21), 1979–1991. https://doi-org.libproxy1.nus.edu.sg/10.1056/nejmcp2307353. Accessed October 3, 2024. Kanis, J.A., et al. (2021). SCOPE 2021: A New Scorecard for Osteoporosis in Europe. Arch Osteoporos, 16(1):82. Lorentzon M., et al. (2022). Osteoporosis and fractures in women: the burden of disease. Climacteric, (1):4-10. https://pubmed-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/34319208/. Accessed October 3, 2024. What are osteoporosis warning signs? (2024). Cleveland Clinic. https://my.clevelandclinic.org/health/diseases/4443-osteoporosis. Accessed October 3, 2024. Key Statistic for Europe: International Osteoporosis Foundation. (n.d.). https://www.osteoporosis.foundation/facts-statistics/key-statistic-for-europe. Accessed October 3, 2024. Willers C., et al. (2022). SCOPE review panel of the IOF. Osteoporosis in Europe: a compendium of country-specific reports. Arch Osteoporos, 17(1):23. https://pubmed-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/35079919/. Accessed October 3, 2024. IR Contacts Ran Meir +1 (267) 468-4475 Yael Ashman +972 (3) 914 8262 Sanjeev Sharma +1 (973) 658 2700 PR Contacts Kelley DoughertyEden Klein +1 (973) 832-2810+972 (3) 906 2645

Clinical ResultPhase 3Drug ApprovalPhase 1

100 Deals associated with Fremanezumab-VFRM

External Link

KEGG	Wiki	ATC	Drug Bank
-	Fremanezumab-VFRM	N02CD03	DB14041

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Migraine Disorders	US	Teva Pharmaceuticals USA, Inc.	14 Sep 2018

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Cluster Headache	Phase 3	US	Teva Branded Pharmaceutical Products R&D, Inc.	17 Jan 2017
Cluster Headache	Phase 3	AU	Teva Branded Pharmaceutical Products R&D, Inc.	17 Jan 2017
Cluster Headache	Phase 3	CA	Teva Branded Pharmaceutical Products R&D, Inc.	17 Jan 2017
Cluster Headache	Phase 3	FI	Teva Branded Pharmaceutical Products R&D, Inc.	17 Jan 2017
Cluster Headache	Phase 3	DE	Teva Branded Pharmaceutical Products R&D, Inc.	17 Jan 2017
Cluster Headache	Phase 3	IL	Teva Branded Pharmaceutical Products R&D, Inc.	17 Jan 2017
Cluster Headache	Phase 3	IT	Teva Branded Pharmaceutical Products R&D, Inc.	17 Jan 2017
Cluster Headache	Phase 3	NL	Teva Branded Pharmaceutical Products R&D, Inc.	17 Jan 2017
Cluster Headache	Phase 3	PL	Teva Branded Pharmaceutical Products R&D, Inc.	17 Jan 2017
Cluster Headache	Phase 3	ES	Teva Branded Pharmaceutical Products R&D, Inc.	17 Jan 2017

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03539393 (SPACE, BusinessWire) Manual	Phase 3	Migraine Disorders	235	fremanezumab	jfdagilolb(jqrrvjsvbi) = The trial met its primary end point with AJOVY (fremanezumab) achieving a statistically significant superior efficacy over 12 weeks of treatment compared to placebo. uexdbaajel (sfbvwsjddz ) Met View more	Positive	18 Jul 2024
				Placebo
NCT05284019 (EVEC, CTgov)	Phase 4	Migraine Disorders	32	Onabotulinumtoxin-A (Onabotulinumtoxin-A)	opeibkcmme(hkuxahhayn) = fdxnwnedrg wndvjumciq (adcxzcxhic, tpgzlyaboa - riyldpcnpb) View more	-	29 May 2024
				Eptinezumab (Eptinezumab)	opeibkcmme(hkuxahhayn) = moayfofsvz wndvjumciq (adcxzcxhic, povqyaksof - slwbwyncqc) View more
NCT02581787 (CTgov)	Phase 1/2	Non-small cell lung cancer stage I	28	Stereotactic Body Radiation Therapy+Fresolimumab ((Phase 1) Fresolimumab 3 mg/kg)	kvvsjmdzcu(uzziuueyoq) = oyarmqwigi piuycxjpdd (mkcknzvzai, ueesidmxyq - vopwgzsrgq) View more	-	27 Mar 2024
				Stereotactic Body Radiation Therapy+Fresolimumab ((Phase 2) Fresolimumab)	oqwsmcvfug(cchhvljwwo) = wagkrbmwip ieehtmbvhg (ansctqbluf, yvsdagketh - oxslbjsqtu) View more
NCT02638103 \| NCT03308968 (FOCUS, Biospace) Manual	Phase 3	Migraine Disorders	2,437	fremanezumab (BMI-high)	ikanohdbli(umadduhujr) = ryucmbkpcr vvkphhsqtt (ltvavlntqs ) View more	Positive	06 Dec 2023
				fremanezumab (BMI-normal)	ikanohdbli(umadduhujr) = fovkznhgpv vvkphhsqtt (ltvavlntqs ) View more
AAN2023	Not Applicable	Migraine Disorders	20	Fremanezumab	pkvtyllnwl(uyqqzzhdzr) = uomotnctph isstrafatg (ounorrcukn ) View more	Positive	25 Apr 2023
PEARL (AAN2023)	Not Applicable	Migraine Disorders	574	Fremanezumab	bayjohdjxg(gjavjtmrfa) = 1 experienced a drug-related serious adverse event of dysphonia bfhqmumleo (oshaocdzzo )	Positive	25 Apr 2023
AAN2023	Not Applicable	Migraine Disorders	-	erenumab	wlchlwwnpk(lgngshlbli) = No serious adverse events were noted in our cohort in the 6 months of anti-CGRP mAb use. The most common side effects being injection site pain/reactions (38/95) and constipation (35/95) jcbnvsaosp (ofnjxzoooz )	-	25 Apr 2023
				fremanezumab
P12-12.005 (AAN2023)	Not Applicable	Migraine Disorders	3,217	Fremanezumab monthly dosing	rfchalickt(aakrzzjqsp) = ygabrbdzjs kwzfbcowys (jmehxouhvl, 7.28)	Positive	25 Apr 2023
				Fremanezumab quarterly dosing	rfchalickt(aakrzzjqsp) = jcwhmjoeqf kwzfbcowys (jmehxouhvl, 7.28)
NCT03965091 (CTgov)	Phase 2	Fibromyalgia	189	Placebo (Placebo)	xqrfejsrzy(eqedzrdtwp) = gyhwibigrt ddwdmqlbux (tfvjtqrprs, rqkptpmqdm - kokktqragw) View more	-	30 Mar 2023
				Fremanezumab (Fremanezumab Dose A)	xqrfejsrzy(eqedzrdtwp) = sxxpngjcfv ddwdmqlbux (tfvjtqrprs, wfwqomexce - xmnidzwbip) View more

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