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Astellas’s Long-Term Safety Data Could Boost Fezolinetant’s Approval Chances

 
• By Joseph Haas

With a pair of successful Phase III pivotal studies in hand, the Japanese pharma reports that its nonhormonal hot flash/night sweats candidate demonstrated safety and tolerability over 52 weeks.

hot flash VMS
Astellas hopes to bring a nonhormonal therapy for hot flashes to market • Source: Alamy

Astellas Pharma, Inc. has already conducted two successful pivotal trials to support upcoming regulatory filings for fezolinetant, its nonhormonal drug candidate for menopause vasomotor symptoms (VMS) like hot flashes and night sweats. But new findings announced 7 March provide additional long-term safety data in a field where safety has been a particular issue, and innovation is needed.

Fezolinetant is a once-daily, oral neurokinin 3 (NK3) receptor antagonist, which acts upon specific neurons that control body temperature to mimic the effects of estrogen. It could provide a novel,...

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