UK approves treatment for hot flushes during the menopause

“Hot flushes and night sweats caused by menopause are common, and can have a significant impact on a woman’s daily life. We are therefore pleased to have authorised Veoza (fezolinetant) for hot flushes and night sweats caused by menopause via our reliance procedure,” said Julian Beach, interim executive director of healthcare quality and access at the MHRA, to the Guardian on Sunday​.

“No medicine would be approved unless it met our expected standards of safety, quality and effectiveness, and we continue to keep the safety of all medicines under close review.”

Hot flashes, also known as vasomotor symptoms, can occur during the menopause in women aged between 40 and 64 as estrogen levels decline and the body is less able to regulate its temperature. While hormonal treatments can be effective in many people, not all patients can benefit and the therapies can increase the risk​ of cardiovascular diseases and cancer.

As an oral non-hormonal treatment, Veoza has the potential to treat hot flashes in women that cannot benefit from hormonal therapy. The drug blocks the action of a signalling molecule called neurokinin B on a specific type of neuron in the brain’s temperature control centre called the hypothalamus.

According to phase 3 results in March 2023, the drug significantly reduced the frequency and severity of vasomotor symptoms compared to a placebo, kicking in as early as week 1 in the trial. However, the treatment is not designed to treat other menopausal symptoms such as mood changes or vaginal dryness.

Astellas says the drug will initially be available only with a prescription and privately from January 5th, 2024. The company is also applying for approval for use of the drug in the National Health Service (NHS).