US FDA approves Astellas Veozah for treatment of vasomotor symptoms due to menopause

Astellas Pharma Inc. announced that the US Food and Drug Administration (FDA) has approved Veozah (fezolinetant) 45 mg once daily for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause on May 12. Veozah is the first nonhormonal neurokinin 3 (NK3) receptor antagonist approved to treat VMS due to menopause. VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause. VMS are the most common symptoms of menopause for which women seek treatment. In the US, about 60% to 80% of women experience these symptoms during or after the menopausal transition. VMS can have a disruptive impact on women's daily activities and overall quality of life. "Today's approval of fezolinetant is a significant and, I believe, long awaited milestone for individuals in the US who experience moderate to severe vasomotor symptoms during the menopausal transition," said Genevieve Neal-Perry, M.D., Ph.D., Chair, UNC School of Medicine Department of Obstetrics and Gynaecology. "This therapy is based on our understanding of the biology behind hot flashes. I'm excited to know that patients will have the option to choose this nonhormonal treatment." Before menopause, there is a balance between estrogens (hormones made by a woman's ovaries) and neurokinin B (NKB), a brain chemical. This balance regulates the body's temperature control centre located in a specific area of the brain. As the body goes through menopause, estrogens decline and this balance is disrupted. This imbalance can lead to very uncomfortable symptoms called VMS. Veozah helps to restore the balance by blocking NKB in the temperature control centre to reduce the number and intensity of hot flashes. "Veozah uses a novel mechanism of action to target the root cause of VMS due to menopause," said Marci English, vice president and head of biopharma development, Astellas. "FDA approval of this new treatment for moderate to severe VMS due to menopause is a testament to Astellas' commitment to delivering innovative therapies in areas of unmet need that have been underserved, including women's health." The approval is supported by results from the BRIGHT SKY programme, which included three phase 3 clinical trials as part of a development program that collectively enrolled over 3,000 individuals across the US, Canada and Europe. 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 due to menopause. Data from the SKYLIGHT 4 safety study further characterizes the long-term safety profile of fezolinetant. Marketing authorization applications for fezolinetant are also under regulatory review in the EU, Switzerland and Australia. Astellas has already reflected the impact from this approval in its financial forecast of the current fiscal year ending March 31, 2024. Veozah (fezolinetant) is a neurokinin 3 (NK3) receptor antagonist indicated for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. Veozah 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"). Veozah 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. 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. Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. The company is 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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