The most common side effects include abdominal pain, diarrhea, insomnia, back pain, hot flush and elevated hepatic transaminases.[9]
Fezolinetant was approved for medical use in the United States in May 2023,[9] and in the European Union in December 2023.[4][5] Fezolinetant is the first neurokinin 3 (NK3) receptor antagonist approved by the US Food and Drug Administration (FDA) to treat moderate to severe hot flashes from menopause.[9] The FDA considers it to be a first-in-class medication.[13]
In March 2023, results from SKYLIGHT 1, a Phase III clinical study of the treatment of moderate to severe hot flashes due to menopause, were published in The Lancet.[14][15]
Unlike GnRH modulators, but similarly to estrogens, NK3 receptor antagonists including fezolinetant and MLE-4901 (also known as AZD-4901, formerly AZD-2624) have been found to alleviate hot flashes in menopausal females.[18][19] This would seem to be independent of their actions on the hypothalamic–pituitary–gonadal axis and hence on sex hormone production.[18][19]NK3 receptor antagonists are anticipated as a useful clinical alternative to estrogens for management of hot flashes, but with potentially reduced risks and side effects.[18][19]
The effectiveness of Veozah to treat moderate to severe hot flashes was demonstrated in each of the first 12-week, randomized, placebo-controlled, double-blind portions of two phase III clinical trials.[9] In both trials, after the first 12 weeks, the females on placebo were then re-randomized to Veozah for a 40-week extension study to evaluate safety.[9] Each trial ran a total of 52 weeks.[9] The average age of the trial participants was 54 years old.[9]
The FDA granted the application for fezolinetant priority review designation.[9] The approval of Veozah was granted to Astellas Pharma US, Inc.[9]
In October 2023, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Veoza, intended for the treatment of hot flushes (vasomotor symptoms) associated with menopause.[4] The applicant for this medicinal product is Astellas Pharma Europe B.V.[4]
Fezolinetant was approved for medical use in the United States in May 2023,[9] and in the European Union in December 2023.[4][5]
^ abcdefg"Veoza EPAR". European Medicines Agency (EMA). 7 December 2023. Archived from the original on 26 December 2023. Retrieved 27 December 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
^ abc"Veoza PI". Union Register of medicinal products. 12 December 2023. Archived from the original on 13 December 2023. Retrieved 26 December 2023.
^"Astellas to Acquire Ogeda SA" (Press release). Astellas Pharma. Archived from the original on 5 November 2021. Retrieved 5 November 2021 – via PR Newswire.
^Lederman S, Ottery FD, Cano A, Santoro N, Shapiro M, Stute P, et al. (April 2023). "Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study". The Lancet. 401 (10382): 1091–1102. doi:10.1016/S0140-6736(23)00085-5. PMID36924778. S2CID257498379.
^World Health Organization (2017). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 77". WHO Drug Information. 31 (1). hdl:10665/330984.
This article incorporates text from this source, which is in the public domain.
