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Astellas Pharma Inc

VEOZAH® (fezolinetant film-coated tablets) Receives Health Canada Approval as First and Only Non-hormonal Treatment for Vasomotor Symptoms (VMS) Associated with Menopause

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

MARKHAM, ON , Dec. 3, 2024 /CNW/ - 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

About the BRIGHT SKY™ Phase 3 Program
The BRIGHT SKY pivotal trials, SKYLIGHT 1™ (NCT04003155) and SKYLIGHT 2™ (NCT04003142), enrolled over 1,000 women with moderate to severe VMS. The trials were double-blinded, placebo-controlled for the first 12 weeks followed by a 40-week treatment extension period.9,10 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.11

About HIGHLIGHT 1™
Fezolinetant is also being investigated for the treatment of moderate to severe VMS in women with breast cancer receiving adjuvant endocrine therapy. HIGHLIGHT 1™ (NCT06440967) is a randomized, placebo-controlled, double-blind, Phase 3 clinical study to assess the efficacy and safety of fezolinetant for the treatment of moderate to severe VMS in women with stage 0 to 3 hormone receptor-positive breast cancer who are receiving adjuvant endocrine therapy. Approximately 540 participants are planned to be randomized 1:1 to fezolinetant or placebo at up to 100 sites globally. The four coprimary endpoints are change in the frequency and severity of moderate to severe VMS from baseline to weeks 4 and 12. Patients will be treated for 52 weeks with a final evaluation at 55 weeks.12

About VEOZAH® (fezolinetant film-coated tablets)
VEOZAH (fezolinetant film-coated tablets) is an oral, once-daily, non-hormonal medicine for the treatment of moderate to severe VMS associated with menopause. VMS are also known as hot flashes or night sweats. Fezolinetant works by blocking neurokinin B (NKB) binding on the kisspeptin/neurokinin/dynorphin (KNDy) neuron, helping restore the balance in the brain's temperature control center (the hypothalamus) to reduce the number and intensity of hot flashes and night sweats.13,14

About Astellas Pharma Canada, Inc.
 Astellas Pharma Canada, Inc. is a Canadian affiliate of Tokyo-based Astellas Pharma Inc., a pharmaceutical company conducting business in more than 70 countries around the world. At Astellas, we strive to become a cutting-edge, value-driven life science innovator. This means working at the forefront of healthcare change to turn innovative science into VALUE for patients. What sets us apart is our focus on patients, our pioneering innovation, our collaborative culture, and the passion of our talented people. Learn more: https://www.astellas.com/ca/.

Astellas Commitment to Women's Health
At Astellas, meeting unmet patient needs goes beyond delivering innovative therapies. As part of our commitment to mid-life women's health, we are investing in awareness and educational initiatives to provide women with the tools needed to advocate for themselves and feel empowered to have informed conversations with their healthcare professionals. As part of our patient-centric approach, we also partner with a range of women's health groups globally to ensure all our activities and initiatives are insight driven and address the diverse needs of menopause experiences.

Cautionary Notes
In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice.

References

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1 VEOZAH Product Monograph. December 2, 2024. Available from: www.veozahmonograph.ca.

2 Peacock K, Carlson K, Ketvertis KM. Menopause. [Updated 2023 Dec 21]. StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK507826/. Accessed October 2024.

3 Monteleone P, Mascagni G, Giannini A, Genazzani AR, Simoncini T. Symptoms of menopause – global prevalence, physiology and implications. Nat Rev Endocrinol. 2018;14(4):199-215. Accessed October 2024.

4 The Silence and the Stigma: Menopause in Canada. Menopause Foundation of Canada, 2023, https://menopausefoundationcanada.ca/wp-content/uploads/2023/01/MFC_The-Silence-and-the-Stigma_Menopause-in-Canada_Oct22_v2.pdf. Accessed October 2024.

5 Menopause and Work in Canada. Menopause Foundation of Canada, 2023, https://menopausefoundationcanada.ca/pdf_files/Menopause_Work_Canada_2023EN.pdf. Accessed October 2024.

6 Lederman S, Ottery F, Cano A et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. The Lancet. March 13, 2023. doi:10.1016/S0140-6736(23)00085-5. Accessed October 2024.

7 Johnson KA, Martin N, Nappi RE, et al. Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocrinol Metab. 2023;108(8):1981-97. doi:10.1210/clinem/dgad058.

8 Neal-Perry G, Cano A, Lederman S, et al. Safety of fezolinetant for vasomotor symptoms associated with menopause: a randomized controlled trial. Obstetrics & Gynecology. March 9, 2023. doi:10.1097/AOG.0000000000005114. Accessed October 2024.

9 ClinicalTrials.gov. A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women Going Through Menopause (Skylight 1). https://www.clinicaltrials.gov/study/NCT04003155. Accessed October 2024.

10 ClinicalTrials.gov. A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women Going Through Menopause - 2 (Skylight 2). https://www.clinicaltrials.gov/study/NCT04003142. Accessed October 2024.

11 ClinicalTrials.gov. A Study to Find Out How Safe Long-term Treatment With Fezolinetant is in Women With Hot Flashes Going Through Menopause (Skylight 4). https://www.clinicaltrials.gov/study/NCT04003389. Accessed October 2024.

12 ClinicalTrials.gov. Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in Women With Breast Cancer Who Are Having Hormone Therapy. https://clinicaltrials.gov/study/NCT06440967?rank=1. Accessed October 2024. Accessed October 2024.

13 Depypere H, Timmerman D, Donders G, et al. Treatment of menopausal vasomotor symptoms with fezolinetant, a neurokinin 3 receptor antagonist: a phase 2a trial. J Clin Endocrinol Metab. 2019;104:5893-5905. Accessed October 2024.

14 Fraser GL, Hoveyda HR, Clarke IJ, et al. The NK3 receptor antagonist ESN364 interrupts pulsatile LH secretion and moderate levels of ovarian hormones throughout the menstrual cycle. Endocrinology. 2015;156:4214-4225. Accessed October 2024.

SOURCE Astellas Pharma Canada, Inc.