Bayer Gets FDA Nod for Novel Drug to Treat Hot Flashes

The FDA signed off on Bayer’s oral therapy elinzanetant for the treatment of moderate to severe hot flashes in menopausal women. The drug will be available in the U.S. in November under the brand name Lynkuet, according to an announcement Friday.

Data from the Phase III OASIS development program supported the FDA’s decision. In August 2024, Bayer released data from OASIS 1 and OASIS 2, touting significant symptom relief in patients treated with Lynkuet. OASIS 1 showed a 55.9% reduction in vasomotor symptoms (VMS) after 4 weeks and 65.2% at week 12, while OASIS 2 detected a 57.9% and 67% VMS improvement at weeks 4 and 12, respectively.

Both studies also showed that patients taking placebo who later switched to Lynkuet likewise experienced VMS reductions.

Bayer followed these data up with another readout in September 2024, this time from the OASIS 3 study, which followed patients for 52 weeks. Results pointed to Lynkuet’s long-term safety and efficacy, with the drug showing a favorable safety profile through one year of follow-up. Lynkuet’s label flags some risks, including daytime impairments and sleepiness, as well as potential pregnancy loss. Lynkuet should not be given to pregnant women.

Efficacy data from OASIS 3 also supported OASIS 1 and OASIS 2’s findings, eliciting a significant 12-week reduction in VMS.

Lynkuet targets neurokinin 1 and neurokinin 3 receptors on neurons, blocking the mechanism of heat generation during hot flashes, the first such drug to target this pathway, according to Bayer. The drug is taken as a gel capsule once daily before sleep.

Aside from these three studies, Bayer also tested Lynkuet in the Phase III OASIS 4 study, which it ran outside the U.S. and focused on women with HR-positive breast cancer on endocrine therapy. Results, released in June this year, likewise demonstrated a significant decrease in VMS at week 4 versus placebo, an effect the drug was able to sustain through 12 weeks.