The MHRA has authorised a non-hormonal medicine, called Veoza, which targets common symptoms of menopause. The UK agency’s approval was made under its reliance procedure following the FDA’s approval of the drug in May 2023. In the US, the drug is marketed as Veozah.
The primary indication for treatment is vasomotor symptoms (VMS) – commonly called hot flushes, and night sweats – which are widely experienced by both menopausal and perimenopausal women.
The active pharmaceutical ingredient of Veoza, fezolinetant, acts directly on the brain by blocking a protein called neurokinin 3 that regulates body temperature, and therefore mitigates VMS, in menopausal women.
VMS affect about 70% of women going through the menopause and can negatively impact many aspects of daily life including sleep, exercise and work.
Hormone replacement therapy has been the most effective treatment choice in menopause, but this can be unsuitable for some women who have a history of breast or ovarian cancer, and blood clots among other conditions. For women who are unable to have hormone replacement therapy, or who do not want to use it, this class of medication has the potential to revolutionise menopause management, according to the British Menopause Society.
The drug is prescription-only and will be available privately from 5 January, according to Astellas, the company which makes the drug. Astellas has also begun the process of applying to the National Institute for Health and Care Excellence which governs whether the medicine would be made available for prescription on the NHS.
“Hot flushes and night sweats caused by menopause are common and can have a significant [negative] impact on a woman’s daily life. We are therefore pleased to have authorised Veoza for hot flushes and night sweats caused by menopause via our reliance procedure,” said Julian Beach, the interim executive director of healthcare quality and access at the MHRA.
Veoza also received marketing authorisation in the EU on 7 December 2023.