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Astellas menopause drug wins hard-fought FDA approval
2023-05-15
临床3期优先审批申请上市上市批准临床结果
On Friday, the U.S FDA approved Astellas Pharma's once daily pill for the treatment of menopause symptoms.
The drug, branded Veozah, is a neurokinin 3 (NK3) receptor antagonist that offers the first nonhormonal treatment for moderate to severe vasomotor symptoms associated with menopause, such as hot flashes and night sweats.
The approval was not without obstacles, coming later than initially expected for Astellas. The Tokyo-based drugmaker's NDA was accepted back in August 2022. The application hinged on three phase 3 trials which enrolled 2,800 women from across the U.S., Canada and Europe. Astellas cashed in its valuable Priority Review voucher to speed up the drug's review, and the drug was assigned a PDUFA date in February. Then, just before its decision date, the FDA pushed back its decision to May 22, 2023.
Astellas first got its hands on fezolinetant in 2017, when it completed the acquisition of Ogeda for $500 million upfront. Now a potential blockbuster, the treatment is projected to reach an annual total of $1.21 billion in U.S. sales by 2032, according to GlobalData's Expiry Model.
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