Non-HRT treatment for menopausal hot flushes approved
UK regulators have become the first in the world to approve the non-hormonal treatment, which is taken as a daily pill.
Trials have found that elinzanetant (brand name Lynkuet) can cut flushes by two thirds and help to ease night sweats.
Hot flushes are the most common symptom of menopause.
Hormone replacement therapy is the most common form of medication used to combat menopausal symptoms.
While HRT has become increasingly popular, many women do not want hormonal treatments which increase risk of cancer and some are not suitable for them.
The new drug, now approved by the Medicines and Healthcare products Regulatory Agency (MHRA) is the first dual-action, non-hormonal pill to address both hot flushes and sleep problems.
It has been licensed 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 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.
It may also help improve sleep problems that often come with menopause.
The medicine manufactured by Bayer is administered in oral tablet form.
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.'
Elinzanetant's approval is based on results from the Oasis clinical trials, which involved more than 1,400 women aged 40 to 65 across several countries.
These studies showed that taking a daily 120mg tablet of elinzanetant significantly reduced the number and intensity of hot flushes and night sweats over 26 to 52 weeks, compared with a placebo.
At 12 weeks, hot flushes were reduced by around two thirds, the research found.
By week 26, more than 80 per cent of women on elinzanetant achieved at least a 50 per cent reduction in hot flush frequency.
In the past five years, the number of women taking HRT has doubled, with an estimated 2.6 million women using it in 2023-24.
Much of the surge is attributed to the 'Davina' effect after Davina McCall spoke about her own experiences of menopause, and led campaigns about the symptoms and potential benefits of HRT.
The numbers on the therapy had fallen sharply, after a landmark trial which was later found to have overstated the risks of breast cancer.
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