Astellas Wins FDA Approval for Hot Flash Treatment in Menopausal Women
BIOMARKER
1. Astellas' fezolinetant, now marketed as Veozah, has been approved by the FDA for the treatment of moderate to severe vasomotor symptoms in menopausal women.
2. Vasomotor symptoms (VMS) are common during menopause, affecting 60-80% of women in the US and lowering their quality of life.
3. Veozah is the first antagonist of the neurokinin 3 (NK3) receptor approved for menopausal symptoms and works by preventing NKB from interacting with its corresponding receptor on hypothalamic neurons.
4. The drug's label bears precautions for higher liver blood test values and common side effects such as stomach pain, diarrhea, insomnia and back pain.
5. Astellas supported its FDA bid for Veozah with data from the BRIGHT SKY clinical development program, which included three Phase III trials enrolling more than 3,000 participants.
6. Both SKYLIGHT 1 and SKYLIGHT 2 studies evaluating Veozah's 30-mg and 45-mg doses over 52 weeks of treatment met their co-primary endpoints.
7. SKYLIGHT 4, the third study under BRIGHT SKY, evaluated the long-term safety of Veozah, and its findings showed both drug doses were safe through 52 weeks of follow-up.
8. Incidence rates for endometrial malignancy and endometrial hyperplasia were within pre-specified limits.
9. The FDA extended the review window by three more months to allow for more time to assess the company's data package.
10. Veozah uses a "novel mechanism of action" to address VMS at its root cause, said Marci English, vice president and head of BioPharma Development at Astellas.