Bayer Gets UK Approval for Hot Flashes Treatment Lynkuet

Bayer has received UK approval to use elinzanetant, branded as Lynkuet, for treating moderate to severe hot flashes linked with menopause. This is the first global approval for the treatment. Elinzanetant demonstrated a favorable safety profile in three studies and submissions for marketing authorizations are underway in the US, EU, and other markets.

Bayer has received approval from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) to use elinzanetant, branded as Lynkuet, for treating moderate to severe hot flashes linked with menopause. This marks the first global approval for the treatment [1].

Developed by Bayer, elinzanetant is a non-hormonal medication designed to alleviate the symptoms of menopause. It works by calming the signals in the brain that cause hot flushes and night sweats, a common symptom of menopause. The drug demonstrated a favorable safety profile in three studies and has been well-tolerated by patients [1].

The MHRA's approval comes after a thorough review of clinical trial data, which showed that elinzanetant significantly reduced hot flushes compared to a placebo. The drug was also linked to fewer sleep disturbances and reported improvements in quality of life among patients [1].

While elinzanetant is not yet available on the National Health Service (NHS) in the UK, it can be purchased privately. The MHRA has recommended that the drug be considered by the National Institute for Health and Care Excellence (NICE) for potential inclusion in the NHS [1].

Bayer is currently submitting marketing authorizations for elinzanetant in the US, EU, and other markets. The company expects that this approval will expand the treatment options for women experiencing menopause symptoms [2].

Menopause and perimenopause can significantly impact quality of life, with hot flushes being one of the most common and disruptive symptoms. The approval of elinzanetant offers a non-hormonal alternative for those who may not be able to, or prefer not to, take hormone-based therapies [1].

References:
[1] https://www.the-independent.com/news/health/hot-flush-pill-menopause-elinzanetant-lynkuet-bayer-b2784970.html
[2] https://www.marketscreener.com/quote/stock/BAYER-AG-436063/news/UK-Clears-Bayer-Medicine-for-Menopause-related-Hot-Flashes-50458178/