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Astellas Pharma announces positive results from phase 3b trial of fezolinetant to treat VMS due to menopause

Thursday, June 29, 2023, 09:00 Hrs  [IST]

Astellas Pharma Inc. announced positive topline results from the phase 3b DAYLIGHT clinical trial for fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause.

The study, comprised of more than 450 women considered unsuitable for hormone therapy, met the primary objective showing statistically significant reduction from baseline in the frequency of moderate to severe VMS to week 24 for fezolinetant 45 mg once daily versus placebo. Serious treatment emergent adverse events (TEAE) occurred in less than 5% of patients, and the most common TEAEs were Covid-19 and headache. Detailed results will be submitted for publication and for consideration at an upcoming medical meeting.

Marci English, vice president, head of biopharma development, Astellas, said: “We are delighted the initial assessment of the DAYLIGHT study further validates the role of fezolinetant in reducing the frequency of moderate to severe VMS due to menopause. These 24-week placebo-controlled data add to our growing base of clinical evidence established in the SKYLIGHT studies and provide additional insights on the safety and effectiveness of fezolinetant in women who cannot or choose not to take hormone therapy.”

Fezolinetant was approved as Veozah by the US Food and Drug Administration (FDA) in May 2023, and Astellas is pursuing regulatory approval for fezolinetant in several other countries and regions, including Europe. The DAYLIGHT study generated additional efficacy and safety data to primarily support health technology assessment (HTA) and reimbursement dossiers throughout Europe.

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

DAYLIGHT (NCT05033886) is a Phase 3b, randomized, double-blind, placebo-controlled, 24-week study to assess the efficacy and safety of fezolinetant in menopausal women aged 40-65 suffering from moderate to severe VMS and considered unsuitable for hormone therapy. A total of 453 women were enrolled at 69 sites in Canada, Europe and Turkey.

The BRIGHT SKY pivotal trials, SKYLIGHT 1 (NCT04003155) and SKYLIGHT 2 (NCT04003142), 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 US, Canada and Europe. SKYLIGHT 4 (NCT04003389) 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 US, Canada and Europe.

Fezolinetant is a neurokinin 3 (NK3) receptor antagonist FDA approved in the US for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. Fezolinetant is not a hormone. VMS are the feelings of warmth in the face, neck, and chest, or sudden intense feelings of heat and sweating (“hot flashes” or “hot flushes”). Fezolinetant works by blocking neurokinin B (NKB) binding on the kisspeptin/neurokinin B/dynorphin (KNDy) neuron to modulate neuronal activity in the thermoregulatory center of the brain (the hypothalamus) to reduce the frequency and severity of moderate to severe VMS due to menopause.

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. The company promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on biology and modality.


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