Menopause product with a lot riding on it reaches FDA review
A significant new product candidate with great potential in the treatment of symptoms associated with the menopause will now be considered by the US regulator for approval.
Japanese drugmaker Astellas Pharma (TYO: 4503) has been developing fezolinetant, an oral molecule, for the treatment of moderate to severe hot flashes or night sweats.
The regulatory package features data from the BRIGHT SKY program, which included three Phase III trials that collectively enrolled over 2,800 women in North America and Europe.
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