A Phase 3, Multicenter, 12-Week, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atogepant for the Preventive Treatment of Chronic Migraine in Pediatric Subjects 12 to 17 Years of Age

Migraine is a disease that most often causes moderate to severe headache on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. The goals of the study are to evaluate adverse events and how well treatment of atogepant works compared to placebo (looks like the study treatment but contains no medicine) in preventing chronic migraine in participants between 12 and 17 years of age.
Atogepant is a medicine currently approved in the United States and Europe for the preventive treatment of migraine in adult patients with migraine and is being studied for the preventative treatment of chronic migraine in participants between the ages of 12 and 17 years. Participants will be randomly assigned to one of the 2 groups to be treated with either atogepant or placebo. This study is double-blinded, which means that neither the patients nor the study doctors know who is given which study treatment. Approximately 420 participants 12 to 17 years of age with chronic migraine will be enrolled at approximately 70 sites across the world.
Participants will receive oral tablets of atogepant or placebo once daily for 12 weeks and will be followed for 4 weeks.
Participants will attend regular visits during the study at a hospital or clinic and the effects of treatment will be checked by completion of a daily diary, medical assessments, blood tests, checking for side effects, and completing questionnaires.

Start Date28 Feb 2025

Sponsor / Collaborator

AbbVie, Inc.

NCT06806293

/ RecruitingPhase 3

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label Extension to Evaluate the Efficacy, Safety, and Tolerability of Atogepant for the Preventive Treatment of Menstrual Migraine

A migraine attack is a moderate or severe headache that usually occurs on one side of the head and is often throbbing or pulsating. The headache is often accompanied by sensitivity to light, sensitivity to sound, nausea, or other symptoms. Menstrual migraine (MM) attacks are migraine attacks that occur in individuals before or during their menstrual period. The main goals of the study are to evaluate the efficacy (how well the medicine works), safety, and tolerability (the degree to which any adverse symptoms can be handled by the patients during the study) of atogepant, compared to placebo (looks like the study treatment but has no medicine in it), for the prevention of MM.
Atogepant is an investigational drug being developed for the preventive treatment of menstrual migraine. Participants are randomly assigned to one of the 2 treatment groups called Arms to receive atogepant or matching placebo. There is 1 in a 2 chance for the participant to receive placebo. Approximately 430 adult female participants with menstrual migraine will be enrolled in approximately 85 sites across the world.
Participants will receive oral atogepant or matching placebo for 3 menstrual cycles during the double-blind period. During the open-label treatment period, participants will receive atogepant during each menstrual cycle.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The safety and tolerability of the treatment will be checked by medical assessments, blood tests, checking for adverse events and completing questionnaires.

Start Date10 Feb 2025

Sponsor / Collaborator

AbbVie, Inc.

NCT06603558

/ RecruitingNot Applicable

Post-marketing Surveillance Study to Evaluate the Safety and Effectiveness of Atogepant for the Prevention of Migraine in Korean Adult Patients

Migraine is a neurological disease characterized by moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound. The study will assess the safety and effectiveness of atogepant for the preventive treatment of migraine in Korean adult patients with chronic migraine or episodic migraine under routine clinical practice.
Atogepant is an approved drug for preventive treatment of migraine in adults. Approximately 3000 adult participants who are prescribed atogepant by their doctors will be enrolled in this study in Korea.
Participants will receive atogepant oral tablets as prescribed by their physician. Participants will be followed for up to week 12.
There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.

Start Date24 Sep 2024

Sponsor / Collaborator

AbbVie, Inc.

100 Clinical Results associated with Atogepant

100 Translational Medicine associated with Atogepant

100 Patents (Medical) associated with Atogepant

146

Literatures (Medical) associated with Atogepant

01 Feb 2025·Pain and Therapy

Correction to: Real‑World Evidence of the Safety and Effectiveness of Atogepant Added to OnabotulinumtoxinA for the Preventive Treatment of Chronic Migraine: A Retrospective Chart Review

Author: Dabruzzo, Brett ; Mechtler, Laszlo ; Rhyne, Christopher ; Blumenfeld, Andrew M ; Cook, Lisa ; Hughes, Olivia ; Manack Adams, Aubrey ; Jenkins, Brian ; Diamond, Merle

01 Feb 2025·Neurology and Therapy

Clinical Pharmacokinetics of Atogepant in Healthy Japanese and White Adults

Article

Author: Boinpally, Ramesh R ; McNamee, Brian

INTRODUCTION:

Atogepant is a calcitonin gene-related peptide receptor antagonist approved for the preventive treatment of migraine in adults in the USA, EU, and several other countries. The objectives of this study were to evaluate the pharmacokinetics (PK) and dose proportionality of atogepant in healthy Japanese participants, evaluate the safety and tolerability of atogepant in Japanese participants, and explore the differences in the PK and safety of atogepant in Japanese vs white participants.

METHODS:

A total of 50 participants (40 Japanese and 10 white) were enrolled into five cohorts; Japanese cohorts were randomized in a 4:1 ratio to atogepant (10 mg, 30 mg, or 60 mg daily dosing and 60 mg twice daily) or placebo. The white participants were randomized to atogepant (60 mg twice daily) or placebo. Doses were administered on day 1 and days 3-8, with those on days 1 and 8 administered after an overnight fast.

RESULTS:

In Japanese participants, atogepant exposure increased with dose, and there was no accumulation with once-daily dosing and minimal (~ 20%) accumulation with twice-daily dosing. Atogepant steady-state exposure appeared to be marginally lower in Japanese participants compared with white participants and was well tolerated. There were no treatment-related adverse events, serious adverse events, clinically significant changes in vital signs, or signs of suicidal ideation or behaviors.

CONCLUSION:

Atogepant exposure increased with dose in healthy Japanese participants and was well tolerated within the dose range tested.

28 Jan 2025·NEUROLOGY

Early Improvements With Atogepant for the Preventive Treatment of Migraine

Article

Author: Gandhi, Pranav ; Neel, Brian ; Dabruzzo, Brett ; Tassorelli, Cristina ; Stokes, Jonathan ; Smith, Jonathan H. ; Liu, Yingyi ; Lipton, Richard B. ; Holle-Lee, Dagny ; Harriott, Andrea M. ; Reuter, Uwe ; Gottschalk, Christopher H. ; Nagy, Krisztian ; Guo, Hua

BACKGROUND AND OBJECTIVES:

Three phase 3 trials demonstrated the efficacy and safety of atogepant in episodic migraine (EM) and chronic migraine (CM) across 12-week treatment periods. This analysis evaluates improvements in efficacy and functional outcomes in the first 4 weeks of treatment with the oral calcitonin gene-related peptide receptor antagonist, atogepant, for the preventive treatment of migraine.

METHODS:

ADVANCE, ELEVATE, and PROGRESS were phase 3, multicenter, randomized, double-blind, placebo-controlled 12-week trials. ADVANCE and ELEVATE included participants aged 18-80 years with >1 year history of EM and 4-14 monthly migraine days (MMDs). ELEVATE required previous treatment failures to 2-4 classes of oral preventives. PROGRESS included participants aged 18-80 years with >1 year history of CM, ≥15 monthly headache days, and ≥8 MMDs. This analysis reports the atogepant 60 mg once daily (QD) and placebo treatment arms. Outcomes included efficacy endpoints (reporting a migraine day on day 1, change from baseline in weekly migraine days [WMDs] at weeks 1-4, and in MMDs in the first 4 weeks) and functional endpoints evaluated by the Activity Impairment in Migraine-Diary (AIM-D) at weeks 1-4 and the European Quality-of-Life 5-Dimension 5-Level (EQ-5D-5L) at weeks 1-2 and 4.

RESULTS:

The modified intent-to-treat population included the ADVANCE (atogepant, n = 222; placebo, n = 214), ELEVATE (atogepant, n = 151; placebo, n = 154), and PROGRESS (atogepant, n = 256; placebo, n = 246) studies. Atogepant-treated participants had greater reductions in the proportion of participants with a migraine day on day 1. The odds ratio compared with placebo was 0.39 (95% CI 0.23-0.67; p = 0.0006) in ADVANCE, 0.53 (95% CI 0.29-0.94, p = 0.031) in ELEVATE, and 0.63 (95% CI 0.43-0.93, p = 0.021) in PROGRESS. Atogepant treatment reduced WMDs at weeks 1-4 and MMDs in the first 4 weeks, and improved AIM-D and EQ-5D-5L at all assessed timepoints for weeks 1-4 compared with placebo.

DISCUSSIONS:

Atogepant 60 mg QD demonstrated superiority to placebo in efficacy and functional measures in the first 4 weeks of treatment across 3 preventive studies, 2 in EM and 1 in CM.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT03777059; NCT04740827; NCT03855137. Submitted: 12/13/2018; 02/02/2021; 02/25/2019. First patient enrolled: 12/14/2018; 03/05/2021; 03/11/2019 clinicaltrials.gov/ct2/show/NCT03777059. clinicaltrials.gov/ct2/show/NCT04740827 clinicaltrials.gov/ct2/show/NCT03855137.

CLASSIFICATION OF EVIDENCE:

This study provides Class II evidence that atogepant 60 mg QD reduces migraine frequency and improves functional outcomes within 4 weeks of initiation in patients with EM and patients with CM.

News (Medical) associated with Atogepant

31 Jan 2025

·www.prnewswire.com

AbbVie Reports Full-Year and Fourth-Quarter 2024 Financial Results

Reports Full-Year Diluted EPS of $2.39 on a GAAP Basis, a Decrease of 12.1 Percent; Adjusted Diluted EPS of $10.12, a Decrease of 8.9 Percent; These Results Include an Unfavorable Impact of $1.52 Per Share Related to 2024 Acquired IPR&D and Milestones Expense Delivers Full-Year Net Revenues of $56.334 Billion, an Increase of 3.7 Percent on a Reported Basis and 4.6 Percent on an Operational Basis Full-Year Global Net Revenues from the Immunology Portfolio Were $26.682 Billion, an Increase of 2.1 Percent on a Reported Basis, or 2.9 Percent on an Operational Basis; Global Humira Net Revenues Were $8.993 Billion; Global Skyrizi Net Revenues Were $11.718 Billion; Global Rinvoq Net Revenues Were $5.971 Billion Full-Year Global Net Revenues from the Oncology Portfolio Were $6.555 Billion, an Increase of 10.8 Percent on a Reported Basis, or 12.0 Percent on an Operational Basis; Global Imbruvica Net Revenues Were $3.347 Billion; Global Venclexta Net Revenues Were $2.583 Billion Full-Year Global Net Revenues from the Neuroscience Portfolio Were $8.999 Billion, an Increase of 16.6 Percent on a Reported Basis, or 16.9 Percent on an Operational Basis; Global Botox Therapeutic Net Revenues Were $3.283 Billion; Global Vraylar Net Revenues Were $3.267 Billion; Combined Global Ubrelvy and Qulipta Net Revenues were $1.664 Billion Full-Year Global Net Revenues from the Aesthetics Portfolio Were $5.176 Billion, a Decrease of 2.2 Percent on a Reported Basis, or 0.6 Percent on an Operational Basis; Global Botox Cosmetic Net Revenues Were $2.720 Billion; Global Juvederm Net Revenues Were $1.177 Billion Reports Fourth-Quarter Diluted Loss Per Share of $0.02 on a GAAP Basis, Inclusive of the Recent Partial Intangible Asset Impairment Charge Related to Emraclidine; Adjusted Diluted EPS of $2.16; These Results Include an Unfavorable Impact of $0.88 Per Share Related to Fourth-Quarter 2024 Acquired IPR&D and Milestones Expense Delivers Fourth-Quarter Net Revenues of $15.102 Billion, an Increase of 5.6 Percent on a Reported Basis and 6.1 Percent on an Operational Basis Provides 2025 Adjusted Diluted EPS Guidance Range of $12.12 to $12.32; Excludes Any Unfavorable Impact Related to Acquired IPR&D and Milestones Expense Reaffirms Expectations for High Single-Digit Compound Annual Revenue Growth Rate through 2029; Raises 2027 Combined Sales Outlook for Skyrizi and Rinvoq to More Than $31 Billion; Updates Outlook for Aesthetics to Deliver High Single-Digit Compound Annual Revenue Growth Rate from 2025 through 2029 NORTH CHICAGO, Ill., Jan. 31, 2025 /PRNewswire/ -- AbbVie (NYSE:ABBV) announced financial results for the fourth quarter and full year ended December 31, 2024. "2024 was a year of significant progress for AbbVie. Our growth platform delivered outstanding results, we advanced our pipeline with key regulatory approvals and promising data, and we strengthened our business through strategic transactions," said Robert A. Michael, chief executive officer, AbbVie. "We are entering 2025 with significant momentum and expect net revenues to exceed their previous peak in just the second full year following the U.S. Humira loss of exclusivity." Fourth -Quarter Results Worldwide net revenues were $15.102 billion, an increase of 5.6 percent on a reported basis, or 6.1 percent on an operational basis. Global net revenues from the immunology portfolio were $7.294 billion, an increase of 4.9 percent on a reported basis, or 5.3 percent on an operational basis. Global Humira net revenues of $1.682 billion decreased 49.1 percent on a reported basis, or 48.7 percent on an operational basis. U.S. Humira net revenues were $1.246 billion, a decrease of 54.5 percent. Internationally, Humira net revenues were $436 million, a decrease of 22.7 percent on a reported basis, or 20.5 percent on an operational basis. Global Skyrizi net revenues were $3.778 billion, an increase of 57.7 percent on a reported basis, or 57.9 percent on an operational basis. Global Rinvoq net revenues were $1.834 billion, an increase of 46.2 percent on a reported basis, or 47.1 percent on an operational basis. Global net revenues from the oncology portfolio were $1.691 billion, an increase of 12.0 percent on a reported basis, or 12.9 percent on an operational basis. Global Imbruvica net revenues were $848 million, a decrease of 6.2 percent, with U.S. net revenues of $625 million and international profit sharing of $223 million. Global Venclexta net revenues were $655 million, an increase of 11.0 percent on a reported basis, or 13.0 percent on an operational basis. Global Elahere net revenues were $148 million. Global net revenues from the neuroscience portfolio were $2.509 billion, an increase of 19.8 percent on a reported basis, or 19.9 percent on an operational basis. Global Botox Therapeutic net revenues were $873 million, an increase of 12.5 percent on a reported basis, or 13.0 percent on an operational basis. Global Vraylar net revenues were $924 million, an increase of 17.1 percent. Global Ubrelvy net revenues were $303 million, an increase of 29.6 percent. Global Qulipta net revenues were $201 million, an increase of 76.4 percent on a reported basis, or 76.2 percent on an operational basis. Global net revenues from the aesthetics portfolio were $1.298 billion, a decrease of 5.2 percent on a reported basis, or 4.4 percent on an operational basis. Global Botox Cosmetic net revenues were $687 million, a decrease of 4.2 percent on a reported basis, or 3.4 percent on an operational basis. Global Juvederm net revenues were $279 million, a decrease of 16.3 percent on a reported basis, or 15.1 percent on an operational basis. On a GAAP basis, the gross margin ratio in the fourth quarter was 70.9 percent. The adjusted gross margin ratio was 83.8 percent. On a GAAP basis, selling, general and administrative (SG&A) expense was 25.5 percent of net revenues. The adjusted SG&A expense was 23.6 percent of net revenues. On a GAAP basis, research and development (R&D) expense was 44.9 percent of net revenues. The adjusted R&D expense was 15.1 percent of net revenues. Acquired IPR&D and milestones expense was 10.4 percent of net revenues. On a GAAP basis, the operating margin in the fourth quarter was negative 9.9 percent. The adjusted operating margin was 34.7 percent. Net interest expense was $610 million. On a GAAP basis, the tax rate in the quarter was 99.0 percent. The adjusted tax rate was 20.2 percent. Diluted loss per share in the fourth quarter was $0.02 on a GAAP basis, inclusive of the recent partial intangible asset impairment charge related to emraclidine. Adjusted diluted EPS, excluding specified items, was $2.16. These results include an unfavorable impact of $0.88 per share related to acquired IPR&D and milestones expense. Note: "Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year's foreign exchange rates. Recent Events AbbVie announced the European Commission (EC) granted marketing authorization for Elahere (mirvetuximab soravtansine) for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who have received one to three prior systemic treatment regimens. Elahere is the first novel therapy approved in the European Union (EU) specifically for patients with FRα positive, platinum-resistant ovarian cancer. At the American Society of Hematology (ASH) Annual Meeting, AbbVie announced updated clinical trial results that showed Epkinly (epcoritamab) combination therapy demonstrated high response rates in adult patients with relapsed or refractory (r/r) follicular lymphoma (FL). The company also announced new results from two ongoing clinical trials which showed Epkinly induced durable complete responses as monotherapy and combination treatment in patients with diffuse large B-cell lymphoma (DLBCL). Epkinly is being co-developed by AbbVie and Genmab. AbbVie and EvolveImmune Therapeutics, an immuno-oncology company developing next-generation biotherapeutics to overcome the therapeutic challenges of cancer cell resistance to current immunotherapies, announced a collaboration and option-to-license agreement to develop multispecific biologics for multiple targets in oncology. The discovery partnership will leverage AbbVie's oncology expertise and EvolveImmune's T-cell engager platform to develop novel antibody-based therapies for solid and hematologic malignancies. AbbVie and Simcere Zaiming announced a partnership to develop a novel trispecific antibody candidate in multiple myeloma (MM). This option-to-license agreement will develop SIM0500, an investigational new drug candidate that is currently in Phase 1 clinical trials in patients with r/r MM. AbbVie and Neomorph announced a collaboration and license agreement that will leverage AbbVie's drug development expertise and Neomorph's leading molecular glue discovery platform to develop novel molecular glue degraders for multiple targets across oncology and immunology. AbbVie announced that it completed its acquisition of Nimble Therapeutics, strengthening AbbVie's pipeline and R&D capabilities. The transaction includes Nimble's lead asset, an investigational oral peptide IL23R inhibitor in preclinical development for the treatment of psoriasis (PsO) as well as Nimble's peptide synthesis, screening, and optimization platform used to help drive rapid discovery and optimization of peptide candidates for a range of targets. AbbVie announced positive topline results from its pivotal Phase 3 TEMPO-2 trial evaluating tavapadon as a flexible-dose monotherapy in early Parkinson's disease (PD). In the study, tavapadon met the primary endpoint, demonstrating a statistically significant improvement from baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III combined score at week 26. Tavapadon also met the key secondary endpoint, demonstrating statistically significant improvement from baseline in the MDS-UPDRS Part II score. Tavapadon has demonstrated positive results across all three Phase 3 TEMPO trials and AbbVie remains on track to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) later this year. AbbVie announced that its two Phase 2 EMPOWER trials investigating emraclidine as a once-daily, oral monotherapy treatment for adults with schizophrenia who are experiencing an acute exacerbation of psychotic symptoms, did not meet their primary endpoint of showing a statistically significant reduction (improvement) in the change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score compared to the placebo group at week 6. Following the results of these trials, AbbVie began an evaluation of the emraclidine intangible asset for impairment which resulted in a significant decrease in the estimated future cash flows for the product. Based on the revised cash flows, the company recorded a non-cash after-tax intangible asset impairment charge of $3.5 billion. AbbVie continues to evaluate information with respect to the Cerevel-related clinical development programs and will monitor the remaining intangible assets of $3.6 billion. AbbVie announced that it completed its acquisition of Aliada Therapeutics. The transaction strengthens AbbVie's neuroscience pipeline and R&D capabilities with the addition of a potential best-in-class disease-modifying therapy for Alzheimer's disease (AD), ALIA-1758, and novel blood-brain barrier (BBB)-crossing technology. Full-Year 2025 Outlook AbbVie is issuing its adjusted diluted EPS guidance for the full-year 2025 of $12.12 to $12.32. The company's 2025 adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred during 2025, as both cannot be reliably forecasted. Long-Term Outlook AbbVie is reaffirming its expectations for a high single-digit compound annual revenue growth rate through 2029. This guidance assumes 2024 as the base year in the compound annual growth rate calculation. AbbVie is raising its long-term outlook for Skyrizi and Rinvoq revenues. The company now expects combined Skyrizi and Rinvoq 2027 revenues of more than $31 billion, an increase of approximately $4 billion compared to previous guidance for combined revenues of more than $27 billion in 2027. This guidance assumes Skyrizi revenues of more than $20 billion and Rinvoq revenues of more than $11 billion in 2027. AbbVie is also updating its outlook for aesthetics revenues. The company now expects a high single-digit compound annual revenue growth rate for aesthetics through 2029. This guidance assumes 2025 as the base year in the compound annual growth rate calculation. About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience and eye care - and products and services across our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on X (formerly Twitter), Facebook, Instagram, YouTube or LinkedIn. Conference Call AbbVie will host an investor conference call today at 8:00 a.m. Central Time to discuss our fourth-quarter performance. The call will be webcast through AbbVie's Investor Relations website at investors.abbvie.com. An archived edition of the call will be available after 11:00 a.m. Central Time. Non-GAAP Financial Results Financial results for 2024 and 2023 are presented on both a reported and a non-GAAP basis. Reported results were prepared in accordance with GAAP and include all revenue and expenses recognized during the period. Non-GAAP results adjust for certain non-cash items and for factors that are unusual or unpredictable, and exclude those costs, expenses, and other specified items presented in the reconciliation tables later in this release. AbbVie's management believes non-GAAP financial measures provide useful information to investors regarding AbbVie's results of operations and assist management, analysts, and investors in evaluating the performance of the business. Non-GAAP financial measures should be considered in addition to, and not as a substitute for, measures of financial performance prepared in accordance with GAAP. Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2023 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. 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Clinical ResultDrug ApprovalPhase 3License out/inPhase 1

26 Dec 2024

·www.drugs.com

Quick Fix? New Migraine Medicine, Qulipta, May Start Working Right Away

THURSDAY, Dec. 26, 2024 -- Migraine patients often suffer a long time before docs zero in on the best dosage for drugs designed to prevent their terrible symptoms. But a recently approved daily migraine pill called Qulipta ( atogepant ) appears to be effective from day one in many patients, clinical trial data shows. Patients taking Qulipta had a 37% to 61% lower risk for experiencing migraine from the very first day they started taking the drug, according to a new report in the journal Neurology . “With many current drugs to prevent migraine, it takes time to find the right dosage for the individual and it can take weeks or even months for it to be most effective,” lead researcher Dr. Richard Lipton , vice chair of neurology with the Albert Einstein College of Medicine in the Bronx, NY, said in a news release. “Some people give up and stop taking the drugs before they reach this point. Plus, many people experience side effects with current treatments. Developing a drug that works both effectively and quickly is critical,” Lipton continued. The U.S. Food and Drug Administration (FDA) approved Qulipta in Sept. 2021. It works by blocking calcitonin gene-related peptide (CGRP), a protein released by the brain’s nerve cells during a migraine attack. For this new study, researchers analyzed results from three prior clinical trials for atogepant to see how quickly patients tended to get relief from the drug. Two of the trials, ADVANCE and PROGRESS, tested the drug in patients with episodic or chronic migraine , respectively. Episodic migraine involves 14 or fewer attack days per month, while chronic migraine involves 15 or more. The third trial, ELEVATE, tested atogepant in people with episodic migraine who hadn’t been helped by other migraine medicines, such as triptans. Results from the three trials showed: Atogepant patients also showed less daily impairment from migraine and overall better quality of life, compared to people taking placebo, results show. “Migraine is the second-leading cause of disability in the overall population and the leading cause of disability in young women, with people reporting negative effects on their relationships, parenting, career and finances,” Lipton said. “Having a treatment that can act quickly and effectively addresses a key need,” Lipton added. This new evidence review was funded by AbbVie, the maker of Qulipta. Qulipta and other CGRP-blocking drugs tend to be much more expensive than older migraine drugs, according to the Association of Migraine Disorders. A 30-day supply of Qulipta costs about $1,160 without insurance or discounts, according to Drugs.com . By comparison, generic triptans can cost as low as $12 a month. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Clinical ResultDrug Approval

26 Dec 2024

·www.drugs.com

Atogepant Superior for Efficacy, Functional Measures in Migraine

THURSDAY, Dec. 26, 2024 -- For adults with migraine , atogepant 60 mg once daily was superior to placebo for efficacy and functional measures of treatment across three trials, according to research published online Dec. 23 in Neurology . Richard B. Lipton, M.D., from the Albert Einstein College of Medicine in Bronx, New York, and colleagues examined improvements in efficacy and functional outcomes in the first four weeks of treatment with atogepant 60 mg once daily for the preventive treatment of migraine. The atogepant and placebo treatment arms from three phase 3, multicenter, randomized trials were included (ADVANCE [222 participants with episodic migraine receiving atogepant and 214 receiving placebo]; ELEVATE [151 participants with episodic migraine receiving atogepant and 154 receiving placebo]; and PROGRESS [256 participants with chronic migraine receiving atogepant and 246 receiving placebo]). The researchers observed greater reductions in the proportion of atogepant-treated participants with a migraine day on day 1. Compared with placebo, the odds ratios were 0.39, 0.53, and 0.63 in ADVANCE, ELEVATE, and PROGRESS, respectively. Reductions in weekly migraine days at weeks 1 to 4 and in monthly migraine days in the first four weeks were seen with atogepant treatment; in addition, at all assessed time points for weeks 1 to 4, Activity Impairment in Migraine-Diary and European Quality-of-Life 5-Dimension 5-Level scores improved compared with placebo. "The analyses reported here demonstrate the early efficacy and functional improvements of atogepant and address a key unmet need of providing preventive treatment options with early benefits across the spectrum of migraine disease state severity," the authors write. Several authors disclosed ties to pharmaceutical companies, including AbbVie, which manufactures atogepant and funded the study. Abstract/Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Clinical ResultPhase 3

100 Deals associated with Atogepant

External Link

KEGG	Wiki	ATC	Drug Bank
D11313	Atogepant	-	DB16098

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Migraine Disorders	US	AbbVie, Inc.	28 Sep 2021

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Migraine Without Aura	Phase 3	CN	AbbVie, Inc.	10 Feb 2025
Migraine Without Aura	Phase 3	JP	AbbVie, Inc.	10 Feb 2025
Migraine Without Aura	Phase 3	TW	AbbVie, Inc.	10 Feb 2025
Acute migraine	IND Approval	CN	AbbVie, Inc.	25 Dec 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03777059 \| NCT03939312 \| NCT03700320 \| NCT03855137 \| NCT02848326 (Pubmed \| Cephalalgia)	Phase 2/3	Migraine Disorders	-	Atogepant 60mg once-daily	nxzxjvamis(ytnsbvfbbj) = isirtafztu uesfxvumdk (csiaauhfpt )	-	01 Dec 2024
				Placebo	jwvzuwinht(gxeuaphlms) = zeahtsqucq aoqjxvilfi (ejtxttstoo ) View more
NCT05264129 (TANDEM, CTgov)	Phase 4	Migraine Disorders	263	Atogepant (Atogepant 60 mg (Period 1))	oyvrcnpxue(vrndmjlabt) = jxjvcavtui vuxvqarblq (nbowxtrxse, zziulaicap - sxajggsncz) View more	-	08 Oct 2024
				Atogepant+Ubrogepant (Atogepant 60 mg + Ubrogepant 100 mg (Period 2))	oyvrcnpxue(vrndmjlabt) = gdfrieuofa vuxvqarblq (nbowxtrxse, nqunpcfgzl - llfbfxdjws) View more
NCT03855137 (PROGRESS, Pubmed \| Neurology)	Phase 3	Migraine Disorders	755	Atogepant 30 mg BID	vuoyemoeiz(wxyjbtuvsp) = cqxpuflfio aywrqsrqtn (tfeygfucbt, -4.0 to -1.5) View more	Positive	23 Jul 2024
EAN2024	Not Applicable	-	-	Atogepant 10 mg	fpxlbropsn(nlpjtuxayx) = nihbhhtwgq jjwkrjnvox (jfkpwgjvul )	-	28 Jun 2024
				Atogepant 30 mg	fpxlbropsn(nlpjtuxayx) = terbzziodn jjwkrjnvox (jfkpwgjvul )
NCT03777059 \| NCT03700320 (ADVANCE, Pubmed)	Phase 3	Migraine Disorders calcitonin gene-related peptide receptor	-	Atogepant 10 mg	fcshyvrrwj(mbznbwllgz) = srruywhmgv gbddfvvqpv (jmpccezhja ) View more	Positive	21 May 2024
				Atogepant 30 mg	fcshyvrrwj(mbznbwllgz) = tblkbuljmi gbddfvvqpv (jmpccezhja ) View more
NCT04740827 \| NCT03855137 \| NCT04686136 (3101-312-002, PRNewswire) Manual	Phase 3	Migraine Disorders	-	Atogepant 60 mg	nsdpunrocb(yrljfozgds) = lktmngvelr gjejhbvgwb (faawvsqfgh ) View more	Positive	12 Apr 2024
P4-12.008 (AAN2024)	Not Applicable	Migraine Disorders calcitonin gene-related peptide	-	Atogepant	tsnuvcambh(swtedegdiy) = arenyfecus pxsdpeguem (lbzznzazhw )	Negative	09 Apr 2024
				CGRP mAbs (eptinezumab, erenumab, fremanezumab, galcanezumab)	tsnuvcambh(swtedegdiy) = nytdeichny pxsdpeguem (lbzznzazhw )
AAN2024	Not Applicable	Migraine Disorders	-	Atogepant 60 mg QD	yovxxjrcnz(qzdxwtosgx): OR = 2.23 (95% CI, 1.4 - 3.55)	-	09 Apr 2024
				Placebo
NCT05264129 (TANDEM, AAN2024)	Phase 4	Migraine Disorders \| Acute migraine calcitonin gene-related peptide (CGRP) receptor antagonist	263	Atogepant 60mg QD	dusjgdtcaf(zqlahmupky) = 8.4% vs 3.2% ixqbyicgsb (abpalyqhcf ) View more	Positive	09 Apr 2024
				Ubrogepant 100mg PRN
AAN2024	Not Applicable	Migraine Disorders	-	OnabotulinumtoxinA	jdburchcjo(kmifotmwfe) = The most commonly reported AEs (≥5%) were constipation roepvhjnrw (iospbvdyyv ) View more	-	09 Apr 2024

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