Astellas Receives Positive CHMP Opinion for VEOZA™ (fezolinetant)
Fezolinetant is an investigational nonhormonal treatment for vasomotor symptoms (VMS) associated with menopause
More than half of women ages 40 to 64 worldwide experience VMS, with rates in Europe ranging from 56% to 97%
Astellas Pharma US, Inc. today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on October 12 adopted a positive opinion relating to the use of VEOZA™ (fezolinetant) 45 mg once daily for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.4 VMS, also known as hot flashes and/or night sweats, are common symptoms of menopause. If approved by the European Commission (EC), fezolinetant will be a first-in-class, nonhormonal treatment option to reduce moderate to severe VMS associated with menopause. Fezolinetant works by blocking neurokinin B (NKB) binding on the kisspeptin/neurokinin B/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.
Marci English, Vice President, Head of BioPharma Development, Astellas
"Today's positive CHMP opinion marks another significant milestone for both fezolinetant and women's health. We are excited to be another step closer to potentially providing a novel and important treatment option to individuals in Europe suffering from moderate to severe VMS associated with menopause."
The positive CHMP opinion is based on the results from the BRIGHT SKY™ program, which included three Phase 3 clinical trials that collectively enrolled over 3,000 individuals across Europe, the U.S. 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.7,8 Data from the SKYLIGHT 4™ safety study further characterizes the long-term safety profile of fezolinetant and was published in Obstetrics & Gynecology.9
The positive opinion will now be reviewed by the EC, which has the authority to approve medicines for European Union member states, as well as Iceland, Norway, Liechtenstein and Northern Ireland.10 The EC has 67 days from the CHMP opinion to issue a final decision. Additionally, the positive opinion allows the submission of a European Commission Decision Reliance Procedure marketing authorization application to the Medicines and Healthcare products Regulatory Agency (MHRA), which has the authority to approve medicines for England, Wales and Scotland following the UK's transition from the European Union.11 A final MHRA decision is anticipated in the coming months.
Astellas has already reflected the impact from this result in its financial forecast of the current fiscal year ending March 31, 2024.
For more information, please see the press release "European Medicines Agency Accepts Astellas' Marketing Authorization Application for Fezolinetant" issued on September 29, 2022.
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 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 Europe, the U.S. and Canada. 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 Europe, the U.S. and Canada.
About VMS Associated with Menopause
VMS, characterized by hot flashes (also called hot flushes) and/or night sweats, are common symptoms of menopause.5,6 Worldwide, more than half of women 40 to 64 years of age experience VMS with rates in Europe ranging from 56% to 97%.1,2,3 The prevalence of moderate to severe VMS in postmenopausal women in Europe has been reported at 40%.12 VMS can have a disruptive impact on women's daily activities and overall quality of life.5
About Fezolinetant
Fezolinetant is an investigational oral, nonhormonal medicine in clinical development 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.13,14,15 There is no guarantee the agent will receive regulatory approval in Europe or become commercially available for the uses being investigated.
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