Bayer wins US approval for menopause drug

Bayer has received US approval for its non-hormonal drug to relieve hot flushes linked to menopause.

The US Food and Drug Administration (FDA) has approved Lynkuet for treating moderate to severe vasomotor symptoms – also known as hot flushes – associated with menopause.

The approval was based on three late-stage studies that showed Lynkuet reduced the frequency and severity of hot flushes and eased sleep disturbances in menopausal women.

The FDA had extended its review of the drug in July but did not raise any concerns regarding its general approvability.

Hot flushes are sudden sensations of heat that spread through the body, often causing sweating and a rapid heartbeat.

They are among the most common symptoms experienced during menopause and can significantly affect quality of life.

As a non-hormonal treatment, Lynkuet offers an alternative for women who cannot or choose not to use hormone replacement therapy.

The approval adds to the growing range of non-hormonal options for managing menopause symptoms and addresses an ongoing unmet need for women seeking alternatives to hormone therapy.