Bayer BAYRY announced that it has submitted a marketing authorization application (MAA) to the European Medicines Agency (“EMA”) for its pipeline candidate elinzanetant.

The MAA is seeking approval of the candidate for the treatment of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) associated with menopause or adjuvant endocrine therapy.

Year to date, shares of Bayer have lost 21.7% against the industry’s growth of 20.6%.

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BAYRY’s Progress With Elinzanetant

Elinzanetant, a dual neurokinin-1 and 3 (NK-1 and 3) receptor antagonist, is in late-stage clinical development for the non-hormonal treatment of moderate to severe VMS associated with menopause or adjuvant endocrine therapy, administered orally once daily.

The EMA submission is based on results from the phase III development program, OASIS, which currently comprises four phase III studies — OASIS 1, 2, 3 and 4.

Data from OASIS 1 and OASIS 2 showed that elinzanetant demonstrated statistically significant reductions in VMS frequency and severity compared to placebo. Elinzanetant also significantly improved sleep disturbances and menopause-related quality of life compared to placebo. The candidate's safety profile was favorable.

Results from the phase III OASIS 3 study further supported efficacy data and sustained safety data of elinzanetant over 52 weeks.

Per a recent survey, 67% of European women reported VMS during their menopause transition.

Last week, the FDA accepted the company’s new drug application for elinzanetant, seeking approval for the treatment of moderate-to-severe VMS.
Bayer continues to submit applications for marketing authorizations of elinzanetant to health authorities globally.

It is also conducting NIRVANA (NCT06112756), an exploratory phase II randomized, parallel-group treatment, double-blind study. The primary objective is to explore the efficacy of elinzanetant on sleep disturbances associated with menopause, as determined by polysomnography.

Approval of New Drugs Key for BAYRY

Bayer wants to strengthen its pharmaceutical portfolio, and the approval of new drugs is important to this end.

A potential approval of elinzanetant in the United States and the EU should be beneficial for BAYRY.

Pipeline setbacks and regulatory setbacks have weighed on the stock in recent times. The late-stage study, OCEANIC-AF, investigating asundexian compared with direct oral anticoagulant Eliquis (apixaban) in patients with atrial fibrillation and at risk for stroke, was stopped early due to the lack of efficacy. This was a major setback, given the candidate’s potential.