Treatment for hot flushes and night sweats accepted for regulatory review by EMA

September 30, 2022 - 2 minutes
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A treatment for moderate to severe vasomotor symptoms (VMS) has been accepted by the European Medicines Agency (EMA) for regulatory review.

Astellas Pharma Inc., submitted a marketing authorization application (MAA) for fezolinetant, an investigational oral, nonhormonal compound.

VMS is characterized by hot flushes and/or night sweats which are common menopausal symptoms.

Hot flushes

The news was announced yesterday (September 29).

Senior vice president of Astellas, Ahsan Arozullah, said: “More than half of women 40 to 64 years of age experience hot flushes during menopause, with limited nonhormonal treatment options.

“The EMA’s acceptance of our MAA for fezolinetant brings us one step closer to advancing a potential first-in-class nonhormonal treatment option for women in Europe who experience VMS associated with menopause, similar to the FDA acceptance of our NDA for women in the U.S.”

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Clinical trials of fezolinetant

The MAA is supported by results from the BRIGHT SKY program, which included three phase 3 clinical trials that collectively enrolled over 2,800 women with VMS 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.

Data from the SKYLIGHT 4 safety study further characterizes the long-term safety profile of fezolinetant. Within the MAA, Astellas proposes a 45 mg daily dose, which is subject to the EMA’s review.

Fezolinetant is an investigational nonhormonal selective neurokinin 3 (NK3) receptor antagonist. The safety and efficacy of fezolinetant are under investigation and have not been established.

This acceptance will have no impact on Astellas’ financial forecasts of the current fiscal year ending March 31, 2023.

Women’s quality of life

The BRIGHT SKY pivotal trials, SKYLIGHT 1 and SKYLIGHT 2, enrolled over 1,000 women with moderate to severe VMS. The trials are double-blinded, placebo-controlled for the first 12 weeks followed by a 40-week treatment extension period. Women were enrolled at over 180 sites within the U.S., Canada and Europe. SKYLIGHT 4 is a 52-week double-blinded, placebo-controlled study designed to investigate the long-term safety of fezolinetant. For SKYLIGHT 4, over 1,800 women with VMS were enrolled at over 180 sites within the U.S., Canada and Europe.

Worldwide, more than half of women 40 to 64 years of age experience VMS with rates in Europe ranging from 56% to 97%. The prevalence of moderate to severe VMS in postmenopausal women in Europe has been reported at 40%. VMS can have a disruptive impact on women’s daily activities and overall quality of life.

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