Veozah is a non-hormonal neurokinin 3 (NK3) receptor antagonist that blocks the activities of the NK3 receptor, which plays a role in the brain’s regulation of body temperature, and comes with a labelled warning for elevated hepatic transaminase, or liver injury
FDA approves Astellas’ Veozah. (Credit: Bruno Guerrero on Unsplash)
Astellas Pharma has received the US Food and Drug Administration (FDA) approval for Veozah (fezolinetant) to treat vasomotor symptoms (VMS) or hot flashes, due to menopause.
Veozah is a non-hormonal neurokinin 3 (NK3) receptor antagonist that blocks the activities of the NK3 receptor, which plays a role in the brain’s regulation of body temperature.
It is the first NK3 receptor antagonist approved, to treat VMS due to menopause, said Astellas.
Th US regulator approved Veozah 45mg dose, administered orally, once a day.
The drug comes with a labelled warning for elevated hepatic transaminase, or liver injury.
Astellas vice president and biopharma development head Marci English said: “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 approval for Veozah is based on results from the BRIGHT SKY programme, which comprises three Phase 3 clinical trials, SKYLIGHT 1, SKYLIGHT 2 and SKYLIGHT 4.
The clinical trial programme enrolled more than 3,000 participants across the US, Canada and Europe.
The SKYLIGHT 1 and SKYLIGHT 2 clinical trials established the efficacy and safety of the drug, for the treatment of moderate to severe VMS due to menopause.
Data from the SKYLIGHT 4 safety study further validated its long-term safety profile.
The most common side effects of Veozah include abdominal pain, diarrhoea, insomnia, back pain, hot flush and elevated hepatic transaminases.
Furthermore, its marketing authorisation applications for Veozah are currently under regulatory review by the authorities in the EU, Switzerland and Australia, said the Japanese drugmaker.
FDA’s Centre for Drug Evaluation and Research office of rare diseases, paediatrics, urologic and reproductive medicine director Janet Maynard said: “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.”