GnRH

Assisted reproductive technology (ART) comprises various medical procedures used to help in conception. Drugs play a major role in these procedures. The use of different classes of drugs in assisted reproduction has gained traction in recent years, due to a rise in prevalence of infertility. These drugs help at various phases of treatment in order to help with hormone regulation, triggered timed ovulation, and the prevention of ovarian hyperstimulation syndrome. Read Report Overview - A decline in fertility rates is anticipated to drive the global assisted reproductive technology drugs treatment market. According to a report published by the United Nations (UN), the total fertility rate was 2.5 children per woman globally in 2015. However, high procedural cost of assisted reproductive techniques and non-supportive government regulations for certain infertility treatment options are anticipated to hamper the market during the forecast period. Request Brochure of Report - Based on drug, the global assisted reproductive technology drugs treatment market can be classified into GnRH agonists, GnRH antagonists, gonadotropins, human chorionic gonadotropins, and others. The GnRH agonints segment is projected to account for a significant share of the market in the near future, as these drugs effectively work on endometriosis and help control the menstrual cycle. In terms of distribution channel, the global assisted reproductive technology drugs treatment market can be categorized into hospital pharmacies, retail pharmacies, and others. The hospital pharmacies segment is expected to constitute a considerable share of the market during the forecast period, because the various processes of assisted reproduction are usually carried out in hospitals as patients need constant monitoring and checkups. Therefore, patients prefer to visit hospitals and buy drugs from hospital pharmacies for their convenience. Request for Custom Research - In terms of region, the global assisted reproductive technology drugs treatment market can be segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America dominates the global market. The region is projected to account for a significant share of the global assisted reproductive technology drugs treatment market during the forecast period due to an increase in the number of infertility cases. According to the Centers for Disease Control and Prevention, in 2015, approximately 15% of couples in the U.S. were involuntarily infertile and depended on ART treatment to have their own child. Additionally, according to a report released by the Centers for Disease Control and Prevention, in 2016, the fertility rate in U.S. dropped to the lowest level ever recorded. This means that fewer babies are being born to women of childbearing age. Europe dominates the global assisted reproductive technology drugs treatment market due to factors such as issues of involuntary childlessness, favorable reimbursement policies, and regulation od ART treatment. Rise in tourism for surrogacy and low cost of the ART procedure in Asia Pacific compared to that in developed countries are driving the assisted reproductive technology drugs treatment market in Asia Pacific. A decline in fertility rates, rise in demand for fertility treatment, and investment by key players in the expansion of fertility clinics are some factors that are likely to propel the assisted reproductive technology drugs treatment market in Middle East & Africa during the forecast period. Pre Book Assisted Reproductive Technology Drugs Treatment Market Report - Major players operating in the global assisted reproductive technology drugs treatment market include AbbVie Inc., Pfizer Inc., Sanofi, Teva Pharmaceutical Industries Ltd., Merck & Co., Inc., Sun Pharma, and Abbott. More Trending Reports by Transparency Market Research: Surgical Kits Market The global society witnessing an unprecedented period of the coronavirus pandemic. The practice of surgery across the globe is witnessing a slowdown in activities. This is predicted to affect growth of the surgical kits market. As such, stakeholders in the value chain are increasing awareness about the new protocols and practices to combat the transmission of COVID-19 during critical surgeries. Acne Scar Treatment Market Unprecedented events caused by the COVID-19 pandemic have led to stressful environments, resulting in acne for both women and men. Stress related to coronavirus has worsen breakouts in individuals. 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KISQALI® is currently the only CDK4/6 inhibitor that has demonstrated statistically significant improvement in overall survival (key secondary endpoint) with various endocrine treatment partners and the broadest spectrum of patients in two Phase III trials in advanced breast cancer.1 At the time of the second interim overall survival analysis, the MONALEESA-3 study met its key secondary endpoint demonstrating a statistically significant improvement in overall survival for the overall population.1 In Canada, 88% of all new breast cancer cases are diagnosed in individuals over the age of 50, and approximately 10% of women diagnosed will have an initial diagnosis of metastatic breast cancer.2,3 DORVAL, QC, March 18, 2021 /CNW/ - Novartis Pharmaceuticals Canada Inc.. (Novartis) is pleased to announce that statistically significant overall survival (OS) results for KISQALI® (ribociclib) in combination therapy have been approved within the KISQALI® Product Monograph. This is the second Phase III trial in which KISQALI® combination therapy met the secondary endpoint of OS at the pre-planned interim analysis.1 The pivotal Phase III MONALEESA-3 was a randomized double-blind, placebo-controlled study of KISQALI® in combination with fulvestrant for the treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer who had received no or only one line of prior endocrine treatment. These OS results have now been approved within the KISQALI® Product Monograph. At the time of the second interim OS analysis, the study met its key secondary endpoint demonstrating a statistically significant improvement in OS for the overall population and was consistent for the prior endocrine therapy subgroups and across all other subgroups.1 "It is compelling to see consistently significant overall survival findings among pre-, peri-, and postmenopausal women," said Dr. Christine Brezden-Masley, Medical Oncologist, Mount Sinai Hospital. "These results lend an added level of confidence to help oncologists make more informed treatment decisions for their advanced or metastatic breast cancer patients." For women living with metastatic breast cancer, also known as Stage IV breast cancer, the cancer has spread beyond the breast to other areas of the body. Cancerous cells can spread anywhere in the body, but they most commonly spread to the bones or other common sites such as, the liver, brain, lungs and skin. This may happen before or after treatment, or it may develop from reoccurring breast cancer.4 Although there have been advancements in early detection and treatment, there is still no cure for metastatic breast cancer.5 "The element of time is front-and-centre for all women living with advanced or metastatic breast cancer, but for women diagnosed at an older age, navigating their disease may require different considerations which can impose an additional layer of concern and worry," said Cathy Ammendolea, Chair of the Board of Directors, Canadian Breast Cancer Network. "Increased overall survival benefit in postmenopausal women offers new hope to many." KISQALI® is indicated in combination with an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women with HR+/HER2- advanced or metastatic breast cancer, as initial endocrine-based therapy. In pre/perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone releasing hormone (LHRH) agonist. KISQALI® is also indicated in combination with fulvestrant for the treatment of postmenopausal women with HR+/HER2- advanced or metastatic breast cancer, as initial endocrine-based therapy or following disease progression on endocrine therapy.1 "At Novartis, we are proud of the previously shared MONALEESA-7 and the recently added MONALEESA-3 overall survival data," said Daniel Hébert, Vice-President, Medical Affairs, Oncology, Novartis Pharmaceuticals Canada Inc. "In a world where 5-year survival rates in metastatic breast cancer remain persistently low, these data sets represent additional steps toward a future in which we hope to envision advanced or metastatic breast cancer as a chronic disease." KISQALI® is now reimbursed in Ontario, Alberta and British Columbia under the respective provincial drug programs, in addition to Quebec, New Brunswick, Nova Scotia, Manitoba and Saskatchewan. Novartis continues to work towards securing coverage across the country. About KISQALI® (ribociclib) KISQALI® is a selective cyclin-dependent kinase inhibitor, a class of drugs that help slow the progression of cancer by inhibiting two proteins called cyclin-dependent kinase 4 and 6 (CDK4/6). These proteins, when over-activated, can enable cancer cells to grow and divide too quickly. Targeting CDK4/6 may play a role in ensuring that cancer cells do not continue to replicate uncontrollably. KISQALI® was developed by the Novartis Institutes for BioMedical Research (NIBR) under a research collaboration with Astex Pharmaceuticals. KISQALI® first received Health Canada approval for use with letrozole on March 2, 2018, for the treatment of postmenopausal women with HR+/HER2- advanced or metastatic breast cancer as first-line endocrine-based therapy based on findings from the pivotal MONALEESA-2 trial. About Novartis in Advanced Breast Cancer Novartis tackles breast cancer with advanced science, collaboration and a passion for transforming patient care. We've taken a bold approach to our research by including patient populations often neglected in clinical trials, identifying new pathways or mutations that may play a role in disease progression and developing therapies that not only maintain, but also improve, quality of life for patients. Our priority over the past 30 years and today is to deliver treatments proven to improve and extend lives for those diagnosed with advanced breast cancer. About Novartis Pharmaceuticals Canada Inc. Novartis Pharmaceuticals Canada Inc., a leader in the healthcare field, is committed to the discovery, development and marketing of innovative products to improve the well-being of all Canadians. In 2020, the company invested $45 million in research and development in Canada. Located in Dorval, Quebec, Novartis Pharmaceuticals Canada Inc. employs approximately 1,000 people in Canada and is an affiliate of Novartis AG, which provides innovative healthcare solutions that address the evolving needs of patients and societies. For further information, please consult . About Novartis Novartis is reimagining medicine to improve and extend people's lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world's top companies investing in research and development. Novartis products reach more than 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 110,000 people of more than 140 nationalities work at Novartis around the world. Find out more at . KISQALI is a registered trademark. References 1 KISQALI® Product Monograph, December 22, 2020. Available at: . Accessed on March 9, 2021. 2 Canadian Breast Cancer Network. Living with Breast Cancer: Senior Women. Available at: . Accessed on March 9, 2021. 3 Canadian Breast Cancer Network. Metastatic Breast Cancer in Canada Infographic. Available at: . Accessed on March 9, 2021. 4 Canadian Breast Cancer Network. What is Metastatic Breast Cancer? Available at: . Accessed on March 9, 2021. 5 Canadian Breast Cancer Network and Rethink Breast Cancer. Living with Metastatic Breast Cancer in Canada. Available at: . Accessed on March 9, 2021. SOURCE Novartis Pharmaceuticals Canada Inc.

Clarivate published its annual “Drugs to Watch” list, and cited four drugs that it expects to be blockbusters—projected to bring in $1 billion in sales annually. There is a possible snag, though—one may struggle to get approved. Biogen and Eisai’s Aducanumab for Alzheimer’s Disease Earlier this year, the U.S. Food and Drug Administration (FDA) extended the review period for Biogen and Eisai's Biologic License Application (BLA) for aducanumab for Alzheimer’s disease. The drug has been fraught with controversy—and unexpected hopes. The decision by the FDA on the drug application was expected on March 7, but is now delayed until June 7, 2021. In March 2019, Biogen and Tokyo-based Eisai, announced they were discontinuing the global Phase III clinical trials, ENGAGE and EMERGE, of aducanumab in patients with mild cognitive impairment for Alzheimer’s and mild Alzheimer’s dementia. They were also discontinuing the EVOLVE Phase II trial and the long-term extension PRIME Phase Ib trial. An independent data monitoring committee indicated they were unlikely to hit their primary endpoint. It appeared to be the final nail in the amyloid theory of Alzheimer’s disease. Aducanumab is an antibody targeting beta-amyloid, one of the proteins that accumulates in the brains of Alzheimer’s patients. But in October 2019, the two companies announced plans to pursue regulatory approval for the drug. It turned out, the Phase III EMERGE trial met its primary endpoint, showing a significant decrease in clinical decline. Biogen presented the findings in the final data analysis in a December conference, and although there was still some skepticism about the overall data, it did appear to be enough to a BLA and the company planned to do so in the second quarter of 2020. What they presented was that the Phase III EMERGE trial met its primary endpoint, showing a significant decrease in clinical decline. Biogen said the data from a subset of patients that received a high enough dose of the drug had significant benefits on measures of cognition and function, including memory, orientation, and language, as well as benefits on activities of daily living. Although many had issues with some of the data, which was very complex, the companies felt they had a strong enough case to submit it to the FDA and were expected to do so this spring. Then, in April 2020, they announced that although the company had begun to submit parts of the BLA, they did not expect to complete it until the third quarter of this year. The submission was completed in August 2020 with ongoing collaboration with the FDA and include data from the Phase III EMERGE and ENGAGE trials, as well as the Phase Ib PRIME study. Biogen has also requested Priority Review. In November 2020, the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee slammed the drug submission, voting 1 yes, 8 no and 2 uncertain on the question, “Does Study 302 (EMERGE), viewed independently and without regard for Study 301 (ENGAGE), provide strong evidence that supports the effectiveness of aducanumab for the treatment of Alzheimer’s disease?” It also voted 0 yes, 7 no and 4 uncertain on whether Study 103 (PRIME) supported the effectiveness of the drug. Again and again, the committee voted against the drug. Apparently the newest delay is related to the FDA requesting additional analyses and clinical data. Biogen complied, and the FDA considered it a Major Amendment to the application, thus requiring additional review time. If approved, and that seems like a big “if,” the Clarivate analysts describe it as a “monumental opportunity to radically change patient care and transform the market.” UCB’s Bimekizumab For Plaque Psoriasis On September 22, 2020, UCB, based in Brussels, Belgium, announced that the FDA and European Medicines Agency (EMA) accepted the company’s BLA and Marketing Authorization Application (MAA), respectively, for bimekizumab for adults with moderate to severe plaque psoriasis. The submissions were based on positive Phase III data readouts. All met their primary endpoints, demonstrated that patients receiving the drug achieved superior skin clearance at week 16 compared to those who received placebo and those who received AbbVie’s Humira (adalimumab). The drug is a humanized monoclonal IgG1 antibody that selectively inhibits both IL-17A and IL17F, two cytokines that drive inflammation. Probably more importantly, given Humira’s ubiquity, bimekizumab appears to have significantly fewer side effects. The Clarivate team wrote, “While bimekizumab is a late-class entrant providing incremental improvement over existing treatment options, it is expected to have best-in-class efficacy and fewer serious side effects.” Takeda and Myovant’s Relugolix for Prostate Cancer Relugolix is an oral drug to treat prostate cancer. But in addition to that, it is being developed for endometriosis and uterine fibroids in women. The Clarivate analysts believe it’s these three shots on goal that increase the drug’s chances of success. The oral formulation also has advantages over injectable GnRH agonist competitors. On December 18, 2020, the FDA approved the drug, which was developed by Myovant Sciences, under the name Orgovyx, for adults with advanced prostate cancer. It is the first oral gonadotropin-releasing hormone (GnRH) receptor antagonist. In May 2018, Takeda and ASKA Pharmaceutical entered into a licensing deal, granting ASKA exclusive commercialization rights for the drug for uterine fibroids and exclusive development and commercialization rights for endometriosis for Japan. Takeda holds commercial rights in Japan and parts of Asia. Myovant Sciences holds rights in other regions. Myovant Sciences was formed by Takeda and Roivant Sciences in June 2016. Bayer and Merck’s Vericiguat for Chronic Heart Failure On January 20, 2021, the FDA approved Verquvo (vericiguat) to reduce the risk of cardiovascular death and heart failure hospitalization following a hospitalization for heart failure or need for outpatient intravenous (IV) diuretics in adults with symptomatic chronic heart failure and ejection fraction less than 45%. The approval was based on data from the pivotal Phase III VICTORIA trial. The drug is jointly developed by Merck and Bayer AG. Clarivate noted, “Vericiguat’s novel mechanism of action should result in its acceptance as an add-on therapy to existing treatments. It will likely find its niche among high-risk HFrEF patients, become a welcome addition to the treatment armamentarium and expand their treatment options.” Most Read Today