CHMP positive for Vezoa (fezolinetant) to treat vasomotor symptoms associated with menopause – Astellas Pharma

Astellas Pharma Inc. 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 Vezoa (fezolinetant) 45 mg once daily for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. 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.

The positive CHMP opinion is based on the results from the BRIGHT SKY program, which included three Phase III 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. Data from the SKYLIGHT 4 safety study further characterizes the long-term safety profile of fezolinetant and was published in Obstetrics & Gynecology.

See- “Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase III randomised controlled study”- Samuel Lederman, MD, Faith D Ottery, MD PhD, Prof Antonio Cano, MD, Prof Nanette Santoro, MD, Prof Marla Shapiro, CM, MDCM Prof Petra Stute, MD et al. Published: March 13,2023-, The Lancet-2023DOI:https://doi.org/10.1016/S0140-6736(23)00085-5.

VOLUME 401, ISSUE 10382, P1091-1102, APRIL 01, 2023.- Journal of Clinical Endocrinology and Metabolism. “Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase III randomised controlled study”-Samuel Lederman, MD, Faith D Ottery, MD PhD, Prof Antonio Cano, MD, Prof Nanette Santoro, MD, Prof Marla Shapiro, CM, MDCM, Prof Petra Stute, MD et al. Published:March 13, 2023DOI:https://doi.org/10.1016/S0140-6736(23)00085-5.

“Safety of Fezolinetant for Vasomotor Symptoms Associated With Menopause. A Randomized Controlled Trial”- Neal-Perry, Genevieve MD, PhD; Cano, Antonio MD; Lederman, Samuel MD; Nappi, Rossella E. MD, PhD; Santoro, Nanette MD; Wolfman, Wendy MD; English, Marci MPH; Franklin, Catherine BS; Valluri, Udaya MS; Ottery, Faith D. MD, PhD.,
Obstetrics & Gynecology 141(4):p 737-747, April 2023. | DOI: 10.1097/AOG.0000000000005114.