The Committee for Medicinal Products for Human Use (CHMP) has recommended Bayer’s elinzanetant for approval in the EU for treatment of moderate to severe vasomotor symptoms (VMS).
Elizanetant is a dual neurokinin (NK)-targeted therapy. The recommendation is for VMS symptoms (commonly called hot flashes) related to menopause or due to adjuvant endocrine therapy (AET) for breast cancer. It would be the first NK-1 and NK-3 receptor antagonist in the EU for these indications.
The endorsement comes after positive results from phase 3 OASIS-1, -2, -3, and -4 clinical trials. The drug met all the primary endpoints and key secondary endpoints, including a significant reduction in VMS frequency compared to the placebo. It also demonstrated a favorable safety profile.
The European Commission is expected to make a final decision about approval in the EU within the next months. The drug is already approved in the UK and it was originally given a PDUFA date of July 26 by the FDA but this was later extended by up to 90 days.