Bayer Provides Regulatory Update on Elinzanetant for the Treatment of Moderate to Severe Hot Flashes Due to Menopause
The FDA has determined additional time is needed for a full review of the NDA submission, including information provided to support the application. The extension to the Prescription Drug User Fee Act (PDUFA) review period is up to 90 days. The FDA did not raise any concern regarding the general approvability of elinzanetant in its correspondence.
'We are confident in the potential of elinzanetant to provide meaningful clinical benefit to women pending regulatory approval,' said Yesmean Wahdan, M.D., Senior Vice President and Head of Medical Affairs, North America, Pharmaceuticals. 'We continue to work with the FDA to make this treatment available for women in menopause with moderate to severe hot flashes. Despite the universal experience of menopause, social stigma and misinformation persist, leaving many women to suffer without treatment and support. It's critical we advance innovation and education in menopause so women can work with their healthcare provider to determine the best option for them.'
The NDA is based on the positive results from the OASIS 1, 2 and 3 Phase III studies evaluating the efficacy and safety of the investigational compound elinzanetant versus placebo. Results from OASIS 1 and 2 were published in August 2024 in The Journal of the American Medical Association (JAMA). Detailed results of the Phase III study OASIS 3 providing supporting efficacy and additional long-term safety data were presented at The Menopause Society (TMS) annual meeting in September 2024.
In the last 30 days, elinzanetant was approved under the brand name Lynkuet™ in the United Kingdom and Canada. Submissions for marketing authorizations for elinzanetant are also ongoing in the EU and other markets around the world.
About Women's Healthcare at Bayer
Women's Health is in Bayer's DNA. As a global leader in women's healthcare, Bayer has a long-standing commitment to delivering science for a better life by advancing a portfolio of innovative treatments. Bayer offers a wide range of effective short- and long-acting birth control methods as well as therapies for menopause management and gynecological diseases. Bayer is also focusing on innovative options to address the unmet medical needs of women worldwide and to broadening treatment choices such as in menopause. Additionally, Bayer intends to provide 100 million women per year in low- and middle- income countries by 2030 with access to family planning by funding multi-stakeholder aid programs for capacity building and by ensuring the supply of affordable modern contraceptives. This is part of the comprehensive sustainability measures and commitments from 2020 onwards and in line with the Sustainable Development Goals of the United Nations.
About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, 'Health for all, Hunger for none,' the company's products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses before special items amounted to 6.2 billion euros. For more information, go to www.bayer.com.
Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
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