BRIEF—Bayer seeks approval for novel hot flashes treatment

Germany’s Bayer has submitted to the US Food and Drug Administration for approval to market elinzanetant for moderate to severe vasomotor symptoms (VMS), commonly known as hot flashes, associated with menopause.

The application is supported by positive results from the Phase III OASIS 1, 2, and 3 clinical studies.

In 2023, the global market for VMS treatments was valued at approximately $16.6 billion and is expected to grow to $17.86 billion in 2024.

Non-hormonal treatments like elinzanetant are gaining attention as alternatives to traditional hormone therapies, which carry certain risks and are not suitable for all women.

Hot flashes are a leading cause for women to seek medical attention during menopause, affecting 1.2 billion women worldwide by 2030.