Britain’s Medicines and Healthcare Products Regulatory Agency (MHRA) this week became the first regulator in the world to approve elinzanetant (Lynkuet) for the treatment of moderate to severe vasomotor symptoms (hot flushes) associated with the menopause.
When oestrogen levels drop during menopause, certain brain cells become overactive and interrupt the body’s ability to control temperature, which leads to hot flushes and night sweats. Elinzanetant, from Bayer, is a new non-hormonal medication which works by calming these signals in the brain, helping bring the body’s temperature control back into balance.
The medicine, administered in capsule form, may also help improve sleep problems that often accompany menopause.
Julian Beach, MHRA interim executive director of healthcare quality and access, said: “Menopausal hot flushes and night sweats can have a significant negative impact on quality of life, and elinzanetant offers a non-hormonal alternative for those who may not be able to, or prefer not to, take hormone-based therapies.”
Elinzanetant’s approval is based on results from the Oasis clinical trials, involving more than 1 400 women aged 40 to 65 across several countries. These studies showed that taking a daily 120 mg tablet of elinzanetant significantly reduced the number and intensity of hot flushes and night sweats over 26 to 52 weeks, compared with a placebo
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