Shots:
- The US FDA has approved Lynkuet for the treatment of mod. to sev. vasomotor symptoms due to menopause based on P-III (OASIS-1, 2, & 3) trials, with commercial availability expected at the start of Nov 2025; MAA is under the EMA’s review
- Efficacy was evaluated in OASIS-1 & 2 trials assessing Lynkuet vs PBO in 796 menopausal women, meeting their 1EP of reduced mod. to sev. VMS at Wks. 4 & 12, incl. day and night hot flashes
- Safety was assessed in P-III (OASIS-1, 2 & 3) trials involving 1,420 women, incl. 627 in OASIS 3 who received Lynkuet or PBO for up to 52wks. to assess long-term safety
Ref: Bayer | Image: Bayer | Press Release
Related News:- Bayer Reports the CHMP’s Positive Opinion of Elinzanetant to Treat Vasomotor Symptoms
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