Latest news with #YesmeanWahdan
Yahoo
25-07-2025
- Health
- Yahoo
Bayer Provides Regulatory Update on Elinzanetant for the Treatment of Moderate to Severe Hot Flashes Due to Menopause
WHIPPANY, N.J., July 25, 2025--(BUSINESS WIRE)--Bayer today announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for elinzanetant. Elinzanetant is the first neurokinin 1 and neurokinin 3 receptor antagonist in late-stage clinical development for the hormone-free treatment of moderate to severe vasomotor symptoms (VMS) 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 BayerWomen'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 BayerBayer 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 Find more information at Follow us on Facebook: Follow us on X: @BayerPharma Forward-Looking StatementsThis 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 The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. View source version on Contacts Media Contact: Colleen Murphy+1 Sign in to access your portfolio
Business Wire
25-07-2025
- Health
- Business Wire
Bayer Provides Regulatory Update on Elinzanetant for the Treatment of Moderate to Severe Hot Flashes Due to Menopause
WHIPPANY, N.J.--(BUSINESS WIRE)--Bayer today announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for elinzanetant. Elinzanetant is the first neurokinin 1 and neurokinin 3 receptor antagonist in late-stage clinical development for the hormone-free treatment of moderate to severe vasomotor symptoms (VMS) 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 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 The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
Yahoo
19-05-2025
- Health
- Yahoo
Dr. Yesmean Wahdan from Bayer Discusses Women's Health Month with YourUpdateTV
May is Women's Health Month – Dr. Yesmean Wahdan Shares Important and Timely Tips to Help Women Prioritize Their Health at Every Life Stage NEW YORK, May 19, 2025 (GLOBE NEWSWIRE) -- May marks Women's Health Month, a timely reminder that while many women prioritize the health of others, their own well-being matters just as much. Recently, Dr. Yesmean Wahdan, Board-Certified OB/GYN and Medical Affairs Head for Women's Health at Bayer, participated in a nationwide satellite media tour to share important advice for women of all ages. Women experience unique and evolving health milestones, and being proactive with annual checkups, including OB/GYN visits, is one of the most important steps they can take. Dr. Wahdan also encourages women to be informed about the health changes that come with aging and to speak openly with healthcare providers about any concerns. Dr. Wahdan's tips included: Prioritize routine care: Annual wellness visits and consistent communication with healthcare providers help women stay on top of evolving health needs. Support hormonal transitions: From premenstrual symptoms to menopause, hormonal shifts can have a significant impact. Education and lifestyle adjustments can help manage symptoms. Focus on gut health and nutrition: A fiber-rich diet supports digestion and plays a key role in mood regulation and overall wellness. Many women also fall short on key nutrients like Vitamin D, Iron, and Vitamin E. Make informed reproductive choices: With many contraceptive options available, consulting a healthcare provider helps ensure that each woman chooses the method best suited to her lifestyle and health needs. For more information, visit About Dr. Yesmean WahdanDr. Yesmean Wahdan, MD is the Vice President for Bayer U.S. Medical Affairs. Dr. Wahdan is an OB/GYN specialist by training with a passion for patients, their care, and medical innovation that drives optimized care for all. She received her bachelor's degree in Cellular and Molecular Biology from Marymount University in Arlington, Virginia and her Medical Degree from Georgetown University School of Medicine in Washington, DC. She completed her OB/GYN residency at combined program at Georgetown University Medical Center and Washington Hospital Center in Washington, DC and has published several abstracts and articles in the field of Women's Health. In her tenure at Bayer, Dr. Wahdan has served as Medical Science Liaison, Medical Director, and most recently is serving as Head of the U.S. Medical Affairs group for Women's Healthcare & Specialty Medicine. * YourUpdateTV is a property of D S Simon Media. The video included and release was part of a media tour that was produced by D S Simon Media on behalf of Bayer Dante MuccigrossoDirector of Media Integration & Client ReportingE: dantem@ 973.524.0104 A video accompanying this announcement is available at in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
