Astellas’ menopause treatment received the FDA’s blessing to be considered for approval five months after the therapy hit a speed bump in a phase 3 trial conducted in Asia.
With FDA’s acceptance of Astellas’ new drug application for fezolinetant, the company is now expecting a regulatory decision by Feb. 22, 2023. The Japanese pharma will use a priority review voucher to accelerate the agency’s work.
Data from the phase 3 BRIGHT SKY program formed the basis of the FDA submission, as well as a filing in Europe. In that program, fezolinetant beat placebo at reducing the frequency and severity of moderate to severe vasomotor symptoms, which include hot flashes and night sweats.
But the same results were not seen a few weeks later when Astellas revealed a limited readout from a late-stage study conducted in Asia that used a 30-mg dose of fezolinetant, The therapy failed to beat placebo despite looking at a similar endpoint.
Astellas, however, does not need this Asia-based study for the FDA or European filings. The company has asked for the FDA to approve a 45-mg dose, which is what was studied in the BRIGHT SKY program.
The agency will have final say over the dosing. Astellas is positioning fezolinetant as a nonhormonal, oral option for women with menopause.
For the priority review voucher, Astellas booked 13.1 billion yen ($97 million) worth of amortization for the intangible asset in the first quarter of fiscal year 2022.
Fezolinetant’s market potential is estimated to be up to $2.3 billion, according to a Jefferies report from March. Astellas acquired fezolinetant in the 2017 takeover of Ogeda, which cost 500 million euros ($550 million) upfront plus a potential 300 million euros in milestones.