Summary: Astellas Pharma Canada announced Health Canada’s approval of Veozah (fezolinetant), a non-hormonal treatment for moderate to severe vasomotor symptoms like hot flashes and night sweats associated with menopause. These symptoms significantly impact women’s quality of life and are often untreated due to stigma and lack of support. Veozah’s approval, supported by data from the BRIGHT SKY clinical program, addresses a major unmet need in menopause care, providing a safe and effective alternative for women.
Key Takeaways:
- Health Canada Approves Non-Hormonal Menopause Treatment: Veozah (fezolinetant) offers a new option for managing moderate to severe vasomotor symptoms, providing relief for women experiencing distressing hot flashes and night sweats.
- Stigma and Lack of Support Leave Symptoms Untreated: Many women face untreated menopausal symptoms due to stigma, which affects their quality of life and can even force some to leave the workforce, costing the Canadian economy billions annually.
- Clinical Trials Validate Safety and Efficacy: Veozah’s approval is based on results from the BRIGHT SKY clinical program, which included over 2,850 participants and demonstrated the treatment’s safety and effectiveness in reducing vasomotor symptoms.
Astellas Pharma Canada Inc announced the Health Canada approval of Veozah (fezolinetant film-coated tablets), a non-hormonal treatment indicated for the treatment of moderate to severe vasomotor symptoms, which include hot flashes and night sweats, associated with menopause.
Menopause is a stage of aging for women that may encompass up to 40% of their lives and is marked by a variety of physical changes. Vasomotor symptoms are the most reported symptoms of menopause and often the most burdensome. Moderate or severe hot flashes and night sweats can cause distress and discomfort and often have a significant, negative impact on a woman’s quality of life.
Stigma associated with menopause often interferes with women discussing their symptoms and receiving adequate support and care from their personal and professional networks—including their employers and healthcare providers. Consequently, many women experience untreated or mismanaged symptoms. It is estimated that one in 10 women leave the workforce due to menopause, resulting in an estimated $3.5-billion cost per year to the Canadian economy.
“While menopause is an inevitable part of aging, the burden placed on women to endure symptoms without appropriate support is unacceptable. We are now witnessing a women’s health movement focused on menopause care, with healthcare professionals at the forefront of breaking down the stigma,” says Marla Shapiro, CM, primary care physician and professor in the Department of Family and Community Medicine at the University of Toronto, in a release. “Women need to know that there are many tools available to support their journey, including preventative care, lifestyle choices, and safe and effective treatment options to help them thrive during their menopausal years. The availability of a new non-hormonal treatment option for women with moderate to severe vasomotor symptoms addresses a substantial unmet need, providing another safe and efficacious tool to help mitigate the burden of hot flashes and night sweats.”
Approvals and Clinical Studies
Health Canada’s approval of Veozah follows approvals in the United States, United Kingdom, Australia, and Europe. Regulatory approvals are based on the results of the BRIGHT SKY program, which included three phase 3 clinical trials as part of a development program that collectively enrolled more than 2,850 patients across Europe, the United States, 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 vasomotor symptoms 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.
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