Astellas may loss nearly $100 Million in a FDA delayed review
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Astellas may loss nearly $100 Million in a FDA delayed review.
On February 19, Astellas announced that the U.S. Food and Drug Administration (FDA) has notified the company that it will extend its original priority review for fezolinetant, a new drug for the treatment of moderate to severe vasomotor symptoms (VMS) caused by menopause.
Prescription Drug User Fee Act (PDUFA) target date. The FDA extended the PDUFA target date by three months to May 22, 2023 to allow more time to complete the review.
Fezolinetant is an oral, non-hormonal therapy indicated for the treatment of moderate to severe VMS in postmenopausal women.
The drug modulates neuronal activity in the thermoregulatory center of the brain (hypothalamus) by blocking the binding of neurokinin B (NKB) to kisspeptin/neurokinin B/dynorphin (KNDy) neurons, thereby reducing the Frequency and severity of moderate to severe VMS.
On June 23, 2022, Astellas submitted a new drug application (NDA) for fezolinetant to the FDA.
It is worth mentioning that Astellas used the Priority Review Voucher (PRV) when submitting the fezolinetant marketing application, which shortened the review time by four months. After the FDA accepted it, the approval decision date was February 22, 2023.
For priority review vouchers, Astellas registered an amortization of intangible assets worth 13.1 billion yen ($97 million) in the first quarter of fiscal 2022. Today, the advantage of shortened review periods provided by Priority Review Vouchers is almost gone.
The use of the Priority Review Voucher reflects Astellas’ confidence in the drug candidate, and the data from the Phase III BRIGHT SKY trial is the basis for Astellas’ submission of fezolinetant to the FDA, as well as its submission to Europe.
In this study, fezolinetant was superior to placebo in reducing the frequency and severity of moderate to severe vasomotor symptoms, including hot flashes and night sweats.
Astellas identified fezolinetant as the main driver of the company’s sales growth. According to a report by Jefferies in March 2022, the market potential of fezolinetant is estimated to be as high as $2.3 billion.
Astellas acquired fezolinetant when it bought Ogeda in 2017, in a deal that cost 500 million euros ($550 million) upfront and had an additional 300 million euros in milestones.
Astellas may loss nearly $100 Million in a FDA delayed review
(source:internet, reference only)
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