Astellas Gets Approval for Menopause Drug

FDA has approved Astellas Pharma’s Veozah (fezolinetant), an oral drug for treating moderate-to-severe vasomotor symptoms (hot flashes) caused by menopause. The drug is the first neurokinin 3 (NK3) receptor antagonist approved for the indication, according to an agency release. It works by binding to and blocking the activities of the NK3 receptor, which plays a role in body temperature regulation in the brain.

Approval was based on data from two Phase 3, placebo-controlled trials. In both trials, the women on placebo were then re-randomized to Veozah for a 40-week extension study to evaluate safety, FDA says.

As part of the approval, FDA is requiring the prescribing information to include a warning for elevated hepatic transaminase, or liver injury. “While on Veozah, routine bloodwork should be performed every three months for the first nine months of using the medication,” the agency says.