ALPMF - Astellas wins FDA approval of hot flashes drug Veozah

2023-05-12 14:42:30 ET

• The US FDA has granted approval to Astellas Pharma's ( OTCPK:ALPMF )( OTCPK:ALPMY ) Veozah (fezolinetant) for hot flashes associated with menopause.
• The agency noted that the drug is the first neurokinin 3 (NK3) receptor antagonist approved for the condition.
• The efficacy of Veozah was demonstrated in two phase 3 trials.
• The labeling for the drug includes a warning on risk of liver injury.
• In February, the FDA extended the review period for Veozah by three months.

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