Veoza: menopause drug to treat hot flashes approved in the UK

The UK has approved a drug that tackles hot flushes in menopausal women. Fezolinetant, sold under the brand name Veoza, is a daily pill that works by regulating a receptor in the area of the brain that releases hormones that control body temperature.

Consultant endocrinologist and internal spokesperson for Veoza manufacturer Astellas, Professor Annice Mukherjee, said: “Veoza reduces flushes and sweats within a few days by directly targeting the menopause flush/sweat mechanism. It doesn’t work through oestrogen and is well tolerated. Menopause can be very disruptive to women, affecting sleep, mood and energy. Veoza will give women another much-needed option for the treatment of Vasomotor symptoms.”

Menopause is a normal, natural change, usually between the ages of 45 and 55, and as women approach the menopause - when their periods permanently stop - their levels of the hormone oestrogen fluctuate and drop, which can cause problematic symptoms - such as the body can think it is overheating.

Veoza helps with this by blocking a protein in the brain called neurokinin B, involved in regulating temperature. But unlike hormone replacement therapy (HRT), it will not alleviate other menopausal symptoms such as mood changes or vaginal dryness.

The drug has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) through the European Commission (EC) Decision Reliance Route - when a pharmaceutical company references a decision made by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in its application.

The MHRA considers the application using the EMA as a reference, but still makes the final decision.

Julian Beach, interim executive director of healthcare quality and access at the MHRA said: “Hot flushes and night sweats caused by menopause are common, and can have a significant impact on a woman’s daily life.”

He added: “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.”

Veoza was also given the green light by the US Food and Drug Administration (FDA) in May 2023.

The National Institute for Health and Care Excellence (Nice) is expected to begin an appraisal of the drug in July 2024, and the process had been set to begin this month but the timeline was revised following a request from Astellas.

It comes after Nice recommended the NHS should use cognitive behaviour therapy (CBT) instead of, or alongside, hormone replacement therapy to combat certain menopause symptoms, including hot flushes.