Latest news with #Elinzanetant
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.
Rhyl Journal
08-07-2025
- Health
- Rhyl Journal
Hot flush pill gets green light for UK use
The Medicines and Healthcare products Regulatory Agency (MHRA) said it is the first regulator in the world to approve elinzanetant, also known as Lynkuet. The treatment, made by Bayer, can be given to women who have vasomotor symptoms, also known as hot flushes, as an alternative to hormone replacement therapy (HRT). HRT can help relieve most menopause and perimenopause symptoms, including hot flushes. But not all patients want or are able to take hormone treatments. At present elinzanetant is not available on the NHS but the green light from the MHRA means that it can be purchased privately in the UK. It is to be considered by the NHS spending watchdog, the National Institute for Health and Care Excellence. Hot flushes and night sweats are one of the most common symptoms of menopause. It is understood that as oestrogen levels decline around menopause, the body's temperature regulation system can be disrupted when certain brain cells become overactive. The new treatment, which is a non-hormonal medication, works by calming these signals in the brain. Clinical trial data showed that the drug was safe and well tolerated and reduced hot flushes compared with a dummy drug, also known as a placebo. You may not have reached #menopause if you're experiencing headaches, night sweats, weight gain, anxiety and depression – but you may be #perimenopausal. Take a look on our website for more information 👉 — Patient (@patient) May 22, 2023 It was also linked to fewer sleep disturbances and women taking it reported a better quality of life compared with those taking the placebo. 'Hot flushes and night sweats associated with menopause can have a significant negative impact on quality of life,' said Julian Beach, the MHRA's interim executive director of healthcare quality and access. 'We are therefore pleased to announce our approval of elinzanetant, which has met the MHRA's standards for safety, quality and effectiveness. 'Elinzanetant offers a non-hormonal alternative for those who may not be able to, or prefer not to, take hormone-based therapies. 'As with all licensed medicines, we will continue to monitor its safety closely as it becomes more widely used.' Women usually go through the menopause when they are aged between 45 and 55, though it can start sooner. During the menopause a woman's periods stop due to lower hormone levels. Menopause and perimenopause can cause symptoms including anxiety, mood swings, brain fog, hot flushes and irregular periods.
Glasgow Times
08-07-2025
- Health
- Glasgow Times
Hot flush pill gets green light for UK use
The Medicines and Healthcare products Regulatory Agency (MHRA) said it is the first regulator in the world to approve elinzanetant, also known as Lynkuet. The treatment, made by Bayer, can be given to women who have vasomotor symptoms, also known as hot flushes, as an alternative to hormone replacement therapy (HRT). HRT can help relieve most menopause and perimenopause symptoms, including hot flushes. But not all patients want or are able to take hormone treatments. At present elinzanetant is not available on the NHS but the green light from the MHRA means that it can be purchased privately in the UK. It is to be considered by the NHS spending watchdog, the National Institute for Health and Care Excellence. Hot flushes and night sweats are one of the most common symptoms of menopause. It is understood that as oestrogen levels decline around menopause, the body's temperature regulation system can be disrupted when certain brain cells become overactive. The new treatment, which is a non-hormonal medication, works by calming these signals in the brain. Clinical trial data showed that the drug was safe and well tolerated and reduced hot flushes compared with a dummy drug, also known as a placebo. You may not have reached #menopause if you're experiencing headaches, night sweats, weight gain, anxiety and depression – but you may be #perimenopausal. Take a look on our website for more information 👉 — Patient (@patient) May 22, 2023 It was also linked to fewer sleep disturbances and women taking it reported a better quality of life compared with those taking the placebo. 'Hot flushes and night sweats associated with menopause can have a significant negative impact on quality of life,' said Julian Beach, the MHRA's interim executive director of healthcare quality and access. 'We are therefore pleased to announce our approval of elinzanetant, which has met the MHRA's standards for safety, quality and effectiveness. 'Elinzanetant offers a non-hormonal alternative for those who may not be able to, or prefer not to, take hormone-based therapies. 'As with all licensed medicines, we will continue to monitor its safety closely as it becomes more widely used.' Women usually go through the menopause when they are aged between 45 and 55, though it can start sooner. During the menopause a woman's periods stop due to lower hormone levels. Menopause and perimenopause can cause symptoms including anxiety, mood swings, brain fog, hot flushes and irregular periods.
Leader Live
08-07-2025
- Health
- Leader Live
Hot flush pill gets green light for UK use
The Medicines and Healthcare products Regulatory Agency (MHRA) said it is the first regulator in the world to approve elinzanetant, also known as Lynkuet. The treatment, made by Bayer, can be given to women who have vasomotor symptoms, also known as hot flushes, as an alternative to hormone replacement therapy (HRT). HRT can help relieve most menopause and perimenopause symptoms, including hot flushes. But not all patients want or are able to take hormone treatments. At present elinzanetant is not available on the NHS but the green light from the MHRA means that it can be purchased privately in the UK. It is to be considered by the NHS spending watchdog, the National Institute for Health and Care Excellence. Hot flushes and night sweats are one of the most common symptoms of menopause. It is understood that as oestrogen levels decline around menopause, the body's temperature regulation system can be disrupted when certain brain cells become overactive. The new treatment, which is a non-hormonal medication, works by calming these signals in the brain. Clinical trial data showed that the drug was safe and well tolerated and reduced hot flushes compared with a dummy drug, also known as a placebo. You may not have reached #menopause if you're experiencing headaches, night sweats, weight gain, anxiety and depression – but you may be #perimenopausal. Take a look on our website for more information 👉 — Patient (@patient) May 22, 2023 It was also linked to fewer sleep disturbances and women taking it reported a better quality of life compared with those taking the placebo. 'Hot flushes and night sweats associated with menopause can have a significant negative impact on quality of life,' said Julian Beach, the MHRA's interim executive director of healthcare quality and access. 'We are therefore pleased to announce our approval of elinzanetant, which has met the MHRA's standards for safety, quality and effectiveness. 'Elinzanetant offers a non-hormonal alternative for those who may not be able to, or prefer not to, take hormone-based therapies. 'As with all licensed medicines, we will continue to monitor its safety closely as it becomes more widely used.' Women usually go through the menopause when they are aged between 45 and 55, though it can start sooner. During the menopause a woman's periods stop due to lower hormone levels. Menopause and perimenopause can cause symptoms including anxiety, mood swings, brain fog, hot flushes and irregular periods.
South Wales Guardian
08-07-2025
- Health
- South Wales Guardian
Hot flush pill gets green light for UK use
The Medicines and Healthcare products Regulatory Agency (MHRA) said it is the first regulator in the world to approve elinzanetant, also known as Lynkuet. The treatment, made by Bayer, can be given to women who have vasomotor symptoms, also known as hot flushes, as an alternative to hormone replacement therapy (HRT). HRT can help relieve most menopause and perimenopause symptoms, including hot flushes. But not all patients want or are able to take hormone treatments. At present elinzanetant is not available on the NHS but the green light from the MHRA means that it can be purchased privately in the UK. It is to be considered by the NHS spending watchdog, the National Institute for Health and Care Excellence. Hot flushes and night sweats are one of the most common symptoms of menopause. It is understood that as oestrogen levels decline around menopause, the body's temperature regulation system can be disrupted when certain brain cells become overactive. The new treatment, which is a non-hormonal medication, works by calming these signals in the brain. Clinical trial data showed that the drug was safe and well tolerated and reduced hot flushes compared with a dummy drug, also known as a placebo. You may not have reached #menopause if you're experiencing headaches, night sweats, weight gain, anxiety and depression – but you may be #perimenopausal. Take a look on our website for more information 👉 — Patient (@patient) May 22, 2023 It was also linked to fewer sleep disturbances and women taking it reported a better quality of life compared with those taking the placebo. 'Hot flushes and night sweats associated with menopause can have a significant negative impact on quality of life,' said Julian Beach, the MHRA's interim executive director of healthcare quality and access. 'We are therefore pleased to announce our approval of elinzanetant, which has met the MHRA's standards for safety, quality and effectiveness. 'Elinzanetant offers a non-hormonal alternative for those who may not be able to, or prefer not to, take hormone-based therapies. 'As with all licensed medicines, we will continue to monitor its safety closely as it becomes more widely used.' Women usually go through the menopause when they are aged between 45 and 55, though it can start sooner. During the menopause a woman's periods stop due to lower hormone levels. Menopause and perimenopause can cause symptoms including anxiety, mood swings, brain fog, hot flushes and irregular periods.
