Yesterday the FDA issued an alert about Astellas’ Veozah (fezolinetant), a medicine used to treat hot flashes due to menopause, stating that it can cause rare but serious liver injury. The agency stated that if there are signs and symptoms suggesting liver injury, halting use of the medicine could prevent worsening liver injury and potentially return liver function to normal.
Tag Archive for: menopause
When it comes to shining the media spotlight on women’s health issues, there exists a culture of silence that demands to be challenged. It’s the 21st Century and health issues that affect half the world’s population are still marginalized in the mainstream media. The stigma and taboo surrounding women’s health issues are deeply entrenched in our society. The reasons for this are complex and related to various socioeconomic factors, societal norms, and ultimately healthcare systems and structures.
Bayer stated that it would request regulatory approval for its menopause drug after the daily pill was shown to ease hot flashes in a third late-stage trial, providing some relief for its pharmaceuticals unit that is reeling from a recent development setback.
Astellas is returning to the Super Bowl to help educate game viewers about VEOZAH and vasomotor symptoms (VMS), the most commonly reported menopause symptoms. The “Fewer Hot Flashes, More Not Flashes” ad features women experiencing common moderate to severe hot flash and night sweat moments that impact their daily lives.
The company said the drug eased hot flashes and improved sleep in two late-stage trials, much-needed good news for the German group’s pharmaceuticals unit that is reeling from a recent development setback.
In May 2023, the menopause drug received FDA approval for treating moderate to severe symptoms. Astellas said in Thursday’s announcement that the late-stage results “will support health technology assessment and reimbursement dossiers throughout Europe.”
Veozah, an oral once-daily medication, is the first FDA-approved NK3 receptor antagonist for hot flashes, a common symptom of menopause that can affect health and quality of life.
The drug failed to reduce the frequency or severity of hot flashes in post-menopausal women.