Germany’s Bayer (ETR: BAYN) this week announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for elinzanetant (brand name: Lynkuet in the UK). This marks the world’s first approval of this dual neurokinin (NK) receptor antagonist (targeting NK-1 and NK-3) for moderate-to-severe vasomotor symptoms (VMS, or hot flashes) associated with menopause.
Clinical Trial Results
The UK marketing authorization represents the first global approval and is based on positive results from the Phase 3 OASIS-1, -2, and -3 studies. These studies evaluated the efficacy and safety of elinzanetant. The drug met all primary endpoints in all three studies and demonstrated a favorable safety profile.
Efficacy and Safety Profile
In OASIS-1 and -2, elinzanetant significantly reduced the mean frequency and severity of moderate-to-severe menopausal VMS compared to placebo at both week 4 and week 12. Over 80% of participants in the elinzanetant group achieved at least a 50% reduction in VMS frequency by week 26, including those who switched from placebo to elinzanetant after week 12. In OASIS-3, elinzanetant demonstrated a statistically significant mean reduction from baseline to week 12 in moderate-to-severe VMS frequency compared to placebo. The reduction in VMS was maintained throughout the study period.
Ongoing Regulatory Applications
Based on the positive results from the Phase 3 clinical development program, marketing authorization applications for elinzanetant are also underway in the US, EU, and other global markets.-Fineline Info & Tech
