Novel hot flushes treatment approved in UK and EU

Woman suffering from hot flushes

Astellas’ Veoza (fezolinetant) will soon be available to some women in the UK suffering from vasomotor symptoms (VMS) associated with menopause following approval by the Medicines and Healthcare Regulatory Agency (MHRA).

Despite VMS, or hot flushes, being a common symptom of menopause, until now, hormone replacement therapy (HRT) was the only treatment.

The drug will be available from 5 January 2024, but only privately until the National Institute for Health and Care Excellence (NICE) makes a decision regarding its use on the NHS.

Veoza was also approved by the European Commission on 7 December 2023 at a dose of 45mg once daily for the treatment of moderate to severe VMS.

Worldwide, more than half of women 40 to 64 years of age experience VMS, with rates in Europe ranging from 56% to 97%.

Professor Rossella Nappi, Full Professor of Obstetrics and Gynecology, Chief of the Research Center for Reproductive Medicine and Director of the Gynecological Endocrinology & Menopause Unit, IRCCS San Matteo Foundation, University of Pavia, said: “I’ve been awaiting the marketing authorisation of fezolinetant. I’m happy to see this advancement in women’s health and that my patients will soon have this new nonhormonal treatment option available to better control their moderate to severe VMS.”

Lack of scientific advancement

Before menopause, there is a balance between oestrogen, and the protein neurokinin B (NKB), which regulates the brain’s temperature control centre. As the body goes through menopause, oestrogen levels decline and this balance is disrupted. Veoza works by blocking NKB binding in the temperature control centre.

Marci English, Vice President, Head of BioPharma Development, Astellas, added: “Fezolinetant’s novel mechanism of action targets the root cause of moderate to severe VMS associated with menopause. We are proud to have developed an innovative treatment option for a condition that has lacked scientific advancement for too long and look forward to making fezolinetant available in countries across the European Union.”

These approvals are based on the results from the BRIGHT SKY programme, which included three Phase III clinical trials that collectively enrolled over 3,000 patients.

Diana Spencer, Senior Digital Content Editor, DDW

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