New treatment option helps fill unmet need for women experiencing hot flashes and night sweats associated with menopause

Today, Astellas Pharma Canada, Inc. is proud to announce the Health Canada approval of VEOZAH® (fezolinetant film-coated tablets), the first and only non-hormonal treatment indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.¹

Menopause is a stage of aging for women that may encompass up to 40 per cent of their lives and is marked by a variety of physical changes.² VMS, which include hot flashes and night sweats, 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.³

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.⁴  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.⁵

Dr. Marla Shapiro C.M., primary care physician and professor in the Department of Family and Community Medicine at the University of Toronto
"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. 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."

Amanda Henderson, Business Unit Head, Women's Health, Astellas Pharma Canada
"At Astellas, we recognize that women's health is an area that has been underserved for too long and are committed to delivering medical innovation that will improve menopause care for millions of Canadians. Health Canada's approval of VEOZAH is being welcomed by physicians and nurse practitioners across Canada as a new treatment to support their patients experiencing moderate to severe VMS (hot flashes and night sweats) associated with menopause. This safe and effective non-hormonal treatment, with its novel mechanism of action, is supported with clinical data demonstrating an improvement in women's quality of life and daily functioning."

Health Canada's approval of VEOZAH follows approvals in the United States (US), United Kingdom (UK), 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 US 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.^6,7 Data from the SKYLIGHT 4™ safety study further characterizes the long-term safety profile of fezolinetant and was published in Obstetrics & Gynecology.⁸