Astellas Pharma Canada, Inc. has announced Health Canada’s approval of Veozah (fezolinetant film-coated tablets) as the pioneering non-hormonal solution designed to address moderate to severe vasomotor symptoms related to menopause.
As women transition through menopause, a phase that may dominate as much as 40 percent of their lifetime, they encounter an array of physical transformations. Vasomotor symptoms, prominently hot flashes and night sweats, stand out as the most prevalent and taxing symptoms, significantly disrupting daily life and well-being.
Despite the commonality of these symptoms, stigma often inhibits women from talking about their experiences and accessing the support they need from their circles, including healthcare and professional environments. Many face undertreatment or mismanagement of these symptoms. Alarmingly, an estimated one in ten women opts out of the workforce due to menopausal challenges, imposing a substantial $3.5 billion annual burden on Canada’s economy.
Dr. Marla Shapiro C.M., a seasoned primary care physician and academic at the University of Toronto, emphasizes that while menopause is an inevitable phase, the expectation for women to suffer symptoms without proper support is misguided. “A women’s health revolution spotlighting menopause care is underway, breaking stigmas and prioritizing effective management. Women should be aware of various supportive tools available, from preventative care, lifestyle adjustments, to reliable treatments. Having a non-hormonal option for VMS is a significant stride towards helping women manage hot flashes and night sweats more effectively,” she stated.
Amanda Henderson, head of women’s health at Astellas Pharma Canada, shares, “Astellas acknowledges the historical neglect of women’s health and is committed to delivering innovations that enhance menopause management for Canadians. The acceptance of Veozah by Health Canada is embraced by healthcare providers nationwide, offering a novel treatment for those troubled by VMS during menopause. With solid clinical backing, it demonstrates improvements in life quality and day-to-day activities.”
This Canadian approval for Veozah succeeds previous authorizations in the U.S., U.K., Australia, and Europe, stemming from the findings of the BRIGHT SKY program. This research initiative comprised three Phase 3 trials, engaging over 2,850 participants globally. Insights from pivotal studies, SKYLIGHT 1 and SKYLIGHT 2, were highlighted in leading medical journals, exploring Veozah’s effectiveness in combatting moderate to severe menopausal vasomotor symptoms. Additional safety insights emerged from SKYLIGHT 4, published in Obstetrics & Gynecology.
The robust SKYLIGHT trials enlisted over 1,000 women, providing compelling evidence of Veozah’s role in symptom relief during a year-long study span. Notably, Veozah is being evaluated for its potential in addressing VMS among women with breast cancer undergoing endocrine therapy globally.
Veozah (fezolinetant) is administered orally, once a day, uniquely targeting the kisspeptin/neurokinin/dynorphin (KNDy) neural pathway to help stabilize temperature regulation in the brain, consequently mitigating the frequency and severity of VMS.
Operating as a branch of Tokyo-headquartered Astellas Pharma Inc., Astellas Pharma Canada is part of a globally recognized company operating in over 70 nations. Astellas strives to spearhead life science innovations and transform pioneering scientific discoveries into tangible benefits for patients.