UK first to approve non-hormonal menopause drug

The UK has become the first country in the world to approve elinzanetant, a non-hormonal treatment for moderate to severe hot flushes linked to menopause.

The once-daily oral capsule, branded Lynkuet, works by calming overactive brain signals that interfere with the body’s temperature control when oestrogen levels fall.

Hot flushes and night sweats occur when certain brain cells become overactive, disrupting the body’s ability to regulate heat.

The Medicines and Healthcare products Regulatory Agency (MHRA) approved the medicine on 8 July for women who cannot, or choose not to, take hormone-based therapies.

The approval is based on results from the OASIS clinical trials involving more than 1,400 women aged 40 to 65 in several countries. The studies showed that a daily 120mg dose significantly reduced the frequency and severity of hot flushes and night sweats over a period of 26 to 52 weeks, compared to a placebo.

The treatment may also help relieve sleep disturbances commonly associated with menopause.

Julian Beach, MHRA interim executive director of healthcare quality and access, said: “Hot flushes and night sweats associated with menopause can have a significant negative impact on quality of life.

“We are therefore pleased to announce our approval of elinzanetant, which has met the MHRA’s standards for safety, quality and effectiveness.

“Elinzanetant offers a non-hormonal alternative for those who may not be able to, or prefer not to, take hormone-based therapies.

“As with all licensed medicines, we will continue to monitor its safety closely as it becomes more widely used.”

The marketing authorisation was granted to Bayer plc following an Access Consortium new active substance work-sharing initiative.

The MHRA is an executive agency of the Department of Health and Social Care, responsible for regulating all medicines and medical devices in the UK.