FDA extends review period for Bayer's elinzanetant for vasomotor symptoms
"The FDA did not raise any concern regarding the general approvability of elinzanetant in its correspondence," according to an anouncement from Bayer.
FDA extends review period for Bayer's elinzanetant for vasomotor symptoms | Image credit: Contemporary OB/GYN
Menopause patients may have to wait a little longer for another treatment for vasomotor symptoms due in part to the FDA's recent decision to extend the review period for Bayer's elinzanetant, the first neurokinin 1 and neurokinin 3 receptor antagonist for the treatment of vasomotor symptoms in menopause.
The July 25, 2025, announcement from Bayer stated the FDA needed additional time, up to 90 days, to review the full new drug application submission (NDA), which included data to support the submission. "The FDA did not raise any concern regarding the general approvability of elinzanetant in its correspondence," according to a company press release.
The NDA submission was supported by positive data from 3 phase 3 studies, OASIS 1, 2, and 3, which investigated the safety and efficacy of elinzanetant vs placebo.
Read about the latest data here: Elinzanetant displays positive phase 3 safety and efficacy data against VMS
“With the consistent positive results from our clinical phase 3 program assessing the efficacy and safety of elinzanetant, we remain confident about elinzanetant’s potential as a new treatment option for moderate to severe vasomotor symptoms associated with menopause”, said Christian Rommel, PhD, member of the Executive Committee of Bayer’s Pharmaceuticals Division and Global Head of Research and Development. “As we continue to work with the FDA during the ongoing review, we are fully committed to making elinzanetant available to women in the U.S. as soon as we receive FDA approval.”
Elinzanetant was recently approved for the treatment of mild to moderate vasomotor symptoms associated with menopause in the United Kingdom and Canada under the brand name Lynkuet.
Reference:
Bayer. Bayer provides regulatory update on elinzanetant in the U.S. Bayer provides regulatory update on elinzanetant in the U.S. Bayer. July 25, 2025. Accessed July 25, 2025. https://www.bayer.com/media/en-us/bayer-provides-regulatory-update-on-elinzanetant-in-the-us/
Newsletter
Get the latest clinical updates, case studies, and expert commentary in obstetric and gynecologic care. Sign up now to stay informed.
S4E3: Myfembree for moderate-to-severe endometriosis pain: Potential for adolescents
March 2nd 2022In this episode of Pap Talk, Contemporary OB/GYN® Associate Editor Lindsey Carr sat down with Jessica Shim, MD, an attending at in the Division of Gynecology, Department of Surgery, Boston Children’s Hospital; Harvard Medical School Boston, Massachusetts, to discuss Myfembree (relugolix, estradiol, and norethindrone acetate tablets; Myovant Sciences, Pfizer) and its possible approval in May 2022.
Listen
S4E1: New RNA platform can predict pregnancy complications
February 11th 2022In this episode of Pap Talk, Contemporary OB/GYN® sat down with Maneesh Jain, CEO of Mirvie, and Michal Elovitz, MD, chief medical advisor at Mirvie, a new RNA platform that is able to predict pregnancy complications by revealing the biology of each pregnancy. They discussed recently published data regarding the platform's ability to predict preeclampsia and preterm birth.
Listen
