Bayer says FDA accepts Lynkuet sNDA, grants priority review

S. S. S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) and granted Priority Review designation for Lynkuet(®) (elinzanetant) under investigation for the treatment of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) in women receiving endocrine therapy for treatment of breast cancer.

S. S. Medical Affairs, Women’s Health at Bayer. “As a global leader in women’s healthcare, this priority review is an important milestone for Bayer and underscores our commitment to women’s health and making treatment options available.

” The sNDA for Lynkuet is based on results of the Phase III OASIS-4 trial. S. (1) Common adverse events during the trial were headache, fatigue, and somnolence. (1) The key findings were presented at ASCO 2025 and simultaneously published in the New England Journal of Medicine (NEJM) in June 2025.

(1) “Endocrine therapy is a standard of care for many women facing HR+ breast cancer and can commonly cause side effects such as vasomotor symptoms,” said OASIS-4 Primary Investigator Fatima Cardoso, MD, FESMO Director Breast Unit, Centre Antoine Lacassagne and Advanced Breast Cancer (ABC) Global Alliance, Nice, France. (2,5,6) Product Indication and Important Safety Information Indication What is LYNKUET(®) (elinzanetant)? LYNKUET is a prescription medicine used to reduce moderate to severe hot flashes (also known as vasomotor symptoms) due to menopause. LYNKUET is not a hormone.

Hot flashes are feelings of warmth in the face, neck, and chest, or sudden intense feelings of heat and sweating. Important Safety Information Do not take LYNKUET if you: are pregnant Before you use LYNKUET, tell your healthcare provider about all of your medical conditions, including if you: have liver problems have a history of seizures or have a condition that may increase your risk of having a seizure are pregnant or planning to become pregnant. LYNKUET may harm your unborn baby.

Women who can become pregnant should talk to their healthcare provider to exclude pregnancy before starting treatment with LYNKUET and use effective birth control during and for 2 weeks after stopping treatment. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. LYNKUET may affect the way other medicines work, and other medicines may affect how LYNKUET works. What should I avoid while taking LYNKUET?

Avoid eating grapefruit or drinking grapefruit juice during treatment with LYNKUET. LYNKUET may cause you to feel drowsy, if you experience this avoid driving and other hazardous activities until these effects go away. LYNKUET can cause serious side effects, including: Central nervous system (CNS) effects and daytime impairment. LYNKUET can cause difficulty staying awake (somnolence) and other nervous system effects including fatigue, having a spinning feeling (vertigo), dizziness, and feeling faint (presyncope).

If you experience these effects, you should not drive or do hazardous activities until these effects go away. Increased liver blood test values. LYNKUET may cause increased liver enzymes. Your healthcare provider will do a blood test to check your liver before you start and 3 months after taking LYNKUET.

Stop taking LYNKUET and tell your healthcare provider right away if you have the following signs or symptoms that suggest liver problems: feeling more tired than you do usually decreased appetite nausea vomiting itching yellowing of the eyes or skin (jaundice) pale feces dark urine pain in the stomach (abdomen) Risk of pregnancy loss. Taking LYNKUET while pregnant may cause loss of pregnancy or stillbirth. If you think you are pregnant, stop taking LYNKUET and tell your healthcare provider right away. Risk of seizure.

Seek medical attention right away if you have loss of consciousness or seizure. Common side effects of LYNKUET include: headache fatigue dizziness feeling drowsy or sleepy stomach (abdominal) pain rash diarrhea muscle spasms Tell your healthcare provider if you have any side effects that do not go away. These are not all the possible side effects of LYNKUET. LYNKUET is available by prescription only.

You are encouraged to report side effects or quality complaints of products to the FDA by visiting or calling 1-800-FDA-1088. For Bayer products, you can report these directly to Bayer by clicking here For important information about LYNKUET, please see the Full Prescribing Information About Lynkuet(®) (elinzanetant) Lynkuet(®) (elinzanetant) 60mg capsules is an FDA-approved, hormone-free prescription treatment for moderate to severe hot flashes due to menopause. Lynkuet is the first and only dual neurokinin (NK) targeted therapy, neurokinin 1 (NK1) and neurokinin 3 (NK3) receptor antagonist approved for the treatment of moderate to severe hot flashes due to menopause.

About the OASIS-1, 2 and 3 trials The FDA approval of Lynkuet(®) (elinzanetant) 60mg capsules is supported by data from three Phase III clinical trials that evaluated the safety and efficacy of Lynkuet for the treatment of moderate to severe hot flashes due to menopause. The efficacy of Lynkuet for the treatment of moderate to severe hot flashes due to menopause was demonstrated in the first 12 weeks of two randomized, double-blind, placebo-controlled, multicenter clinical trials, OASIS-1 and OASIS-2, in 796 menopausal women.

The co-primary efficacy endpoints in both trials were the mean change in frequency and severity of moderate to severe hot flashes from baseline to weeks 4 and 12, including day and night hot flashes. The safety of Lynkuet was evaluated in three randomized, double-blind, placebo-controlled, multicenter clinical trials (OASIS-1, OASIS-2 and OASIS-3) in 1,420 women. In OASIS-3, 627 women received Lynkuet or placebo for up to 52 weeks to evaluate long-term safety. 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.

6 billion euros. 8 billion euros. Find more information at Follow us on Facebook: Follow us on X: @BayerPharma 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. References 1. Cordoso, F, Parke S, Brennan DJ, et.

al. Elinzanetant for Vasomotor Symptoms from Endocrine Therapy for Breast Cancer. N Engl J Med 2025;393:753-763. 2.

LYNKUET® (elinzanetant) [Prescribing Information]. ; August 2026. 3. Huang H, Wei T, Zhang A, et al.

Trends in the incidence and survival of women with hormone receptor-positive breast cancer from 1990 to 2019: a large population-based analysis. Sci Rep. 2024;14(1):23690. Published 2024 Oct 10.

1038/s41598-024-74746-1 4. Burstein HJ, Temin S, Anderson H, et al. Adjuvant endocrine therapy for women with hormone receptor-positive breast cancer: American society of clinical oncology clinical practice guideline focused update. J Clin Oncol.

2014;32(21):2255-2269. 2258 5. Pinkerton JV, Simon JA, Joffe H, et al. Elinzanetant for the treatment of vasomotor symptoms associated with menopause: OASIS 1 and 2 randomized clinical trials.

JAMA. 2024;332(16):1343-1354. 14618 6. Panay N, Joffe H, Maki PM, et al.

Elinzanetant for the treatment of vasomotor symptoms associated with menopause: a phase 3 randomized clinical trial. JAMA Intern Med. Published online September 8, 2025. com) +1-862-431-8817