USA — Japanese leading pharmaceutical company, Astellas Pharma, has achieved a significant milestone with the approval of Veozah (fezolinetant) by the US Food and Drug Administration (FDA).
This approval allows Veozah to be used as a treatment for vasomotor symptoms (VMS), commonly known as hot flashes, associated with menopause.
Veozah is a non-hormonal neurokinin 3 (NK3) receptor antagonist that works by blocking the activity of the NK3 receptor in the brain, which is involved in regulating body temperature.
It is the first NK3 receptor antagonist to receive FDA approval for the treatment of VMS in menopause, marking a groundbreaking advancement in women’s health, according to Astellas.
The FDA has approved Veozah in a 45mg dose, to be taken orally once a day. However, it is important to note that the drug carries a warning regarding the risk of elevated hepatic transaminase, which is associated with liver injury.
Marci English, Vice President and Head of Biopharma Development at Astellas, expressed the company’s excitement, stating, “Veozah uses a novel mechanism of action to target the root cause of VMS due to menopause.
FDA approval of this new treatment for moderate to severe VMS due to menopause is a testament to Astellas’ commitment to delivering innovative therapies in areas of unmet need that have been underserved, including women’s health.”
The FDA’s approval of Veozah is based on the comprehensive results from the BRIGHT SKY program, which consisted of three Phase 3 clinical trials: SKYLIGHT 1, SKYLIGHT 2, and SKYLIGHT 4.
These trials involved over 3,000 participants from the United States, Canada, and Europe. SKYLIGHT 1 and SKYLIGHT 2 demonstrated the efficacy and safety of Veozah in treating moderate to severe VMS in menopause, while the SKYLIGHT 4 safety study further confirmed its long-term safety profile.
Common side effects of Veozah include abdominal pain, diarrhea, insomnia, back pain, hot flushes, and elevated hepatic transaminases.
Astellas has also submitted marketing authorization applications for Veozah to regulatory authorities in the European Union, Switzerland, and Australia, signaling their commitment to making this treatment option available to women worldwide.
Janet Maynard, Director of the Office of Rare Diseases, Paediatrics, Urologic, and Reproductive Medicine at the FDA’s Centre for Drug Evaluation and Research, acknowledged the significance of this approval, stating, “Hot flashes as a result of menopause can be a serious physical burden on women and impact their quality of life.
“The introduction of a new molecule to treat moderate to severe menopausal hot flashes will provide an additional safe and effective treatment option for women.”
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