ESN364

Astellas to Present Findings from Phase 3 Long-Term Safety Study of Fezolinetant in Oral Session at The North American Menopause Society 2022 Annual Meeting

Retrieved on: 
Wednesday, October 12, 2022
BRIGHT, Modality, Woman, Fezolinetant, Advertising, Risk, Hypothalamus, Patient, Research, Climacteric, Multimedia, VMS, Knowledge, Gold, Menopause, Veni, vidi, vici, Health, NKB, Peri, Biology, LH, Safety, Association, ESN364, Brain, GL, Menstrual cycle, Waldbaum's, Flash, Health and Quality of Life Outcomes, Endocrinology, Birth control, Pharmaceutical industry, Wood drying, Astellas Pharma

TOKYO, Oct. 12, 2022 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") will present 52-week results from the Phase 3 SKYLIGHT 4™ clinical study evaluating the safety and tolerability of fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. The results will be featured in an oral presentation October 13 at The North American Menopause Society Annual Meeting. VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause.1,2

Key Points: 
  • SKYLIGHT 4 ( NCT04003389 ) is a 52-week double-blinded, placebo-controlled study designed to investigate the long-term safety of fezolinetant.
  • There is no guarantee the agent will receive regulatory approval or become commercially available for the uses being investigated.
  • Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world.
  • A phase 2b, randomized, placebo-controlled, double-blind, dose-ranging study of the neurokinin 3 receptor antagonist fezolinetant for vasomotor symptoms associated with menopause.

European Medicines Agency Accepts Astellas' Marketing Authorization Application for Fezolinetant

Retrieved on: 
Friday, September 30, 2022
VMS, TSE, Health and Quality of Life Outcomes, Fezolinetant, Health, Safety, Menstrual cycle, Development, Hypothalamus, Woman, Advertising, BRIGHT, Brain, FDA, Prevalence, Peri, European Medicines Agency, Association, Knowledge, SKY, European Commission, Senior, NKB, ESN364, LH, NDA, Climacteric, Patient, Menopause, Worldwide, Quality of life, MAA, Waldbaum's, Flash, Endocrinology, Research, Royal commission, Multimedia, Veni, vidi, vici, EMA, Modality, Biology, Health insurance, Pharmaceutical industry, Birth control, Astellas Pharma

TOKYO, Sept. 29, 2022 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced the European Medicines Agency (EMA) has accepted for regulatory review the company's marketing authorization application (MAA) for fezolinetant, an investigational oral, nonhormonal compound seeking approval for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause.1,2

Key Points: 
  • Data from the SKYLIGHT 4 safety study further characterizes the long-term safety profile of fezolinetant.
  • The safety and efficacy of fezolinetant are under investigation and have not been established.
  • The BRIGHT SKY pivotal trials, SKYLIGHT 1 ( NCT04003155 ) and SKYLIGHT 2 ( NCT04003142 ), enrolled over 1,000 women with moderate to severe VMS.
  • SKYLIGHT 4 ( NCT04003389 ) is a 52-week double-blinded, placebo-controlled study designed to investigate the long-term safety of fezolinetant.