Bayer Submits NDA of Elinzanetant, Seeking Approval in the US for Vasomotor Symptoms Treatment
Shots:
- Bayer has submitted NDA of elinzanetant (dual NK-1 & 3 receptor antagonist) to the US FDA for treating moderate to severe vasomotor symptoms (VMS) linked to menopause. Submissions to other regulatory bodies for the same is planned
- Submission was based on P-III (OASIS) trials, with OASIS 1 (n=396) & 2 (n=400) assessing the safety & efficacy of elinzanetant (120mg, oral, QD) vs PBO for 26wks. & OASIS 3 (n=628) assessing the drug for 52wks. to treat moderate-to-severe VMS in postmenopausal women (40-65yrs.)
- Results demonstrated reduction in the frequency & severity of VMS. Similar improvements were observed in 2EPs of OASIS 1 & 2, incl. VMS frequency reduction at wk.1, improved sleep disturbances & menopause-related QoL
Ref: Bayer | Image: Bayer
Related News:- Bayer Reports Data from the P-III (OASIS 3) Trial of Elinzanetant for Treating Vasomotor Symptoms in Postmenopausal Women
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
