Astellas Pharma's treatment for hot flashes and night sweats approved

2023-12-11

上市批准临床3期临床结果

Astellas Pharma Inc. made the announcement today (December 11) that the EC, on December 7, approved Veozatm (fezolinetant) 45mg once daily for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.

Rossella Nappi is 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.

She said: “I’ve been awaiting the marketing authorization of fezolinetant. I’m happy to see this advancement in women’s health and that my patients will soon have this new non-hormonal treatment option available to better control their moderate to severe VMS.”

VMS, also known as hot flashes and/or night sweats, are common symptoms of menopause. Worldwide, more than half of women 40 to 64 years of age experience VMS, with rates in Europe ranging from 56% to 97%.

Menopausal women in Europe

The prevalence of moderate to severe VMS in postmenopausal women in Europe has been reported at 40% and has been shown to have a disruptive impact on women’s daily activities and overall quality of life.

Marci English, vice president, head of BioPharma Development at Astellas, said: “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.”

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The company explains that before menopause, there is a balance between estrogens, a female sex hormone, and a protein made by the brain known as neurokinin B (NKB) that regulates the brain’s temperature control center. As the body goes through menopause, estrogen levels decline and this balance is disrupted, which can lead to VMS. By blocking NKB binding in the temperature control center, fezolinetant reduces the number and intensity of hot flashes and night sweats.

Clinical trials for menopause

This approval follows a positive opinion issued in October by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based on the results from the BRIGHT SKY program, which included three phase 3 clinical trials as part of a development program that collectively enrolled over 3,000 across Europe, the U.S., and Canada.

Results from the SKYLIGHT 1 and SKYLIGHT 2 pivotal trials characterize the efficacy and safety of fezolinetant for the treatment of moderate to severe VMS associated with menopause and were published in The Lancet and The Journal of Clinical Endocrinology & Metabolism, respectively.

Data from the SKYLIGHT 4 safety study further characterizes the long-term safety profile of fezolinetant and was published in Obstetrics & Gynecology.

The EC marketing authorization for fezolinetant is applicable in the European Union (EU) Member States, as well as Iceland, Norway, and Liechtenstein. Fezolinetant was also approved in Switzerland on December 4, 2023.

Astellas has already reflected the impact of this matter in its financial forecast for the current fiscal year ending March 31, 2024.

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