Astellas' menopause drug crosses FDA finish line after costly delay

After Astellas’ shot at a speedy FDA approval for its menopause drug was derailed in February, the therapy has finally crossed the FDA finish line.

The drug, branded as Veozah, won FDA approval to treat moderate to severe menopause-related vasomotor symptoms. It's the first nonhormonal neurokinin 3 (NK3) receptor antagonist approved to treat the condition.

It’s been a bit of a bumpy road to the green light. After shelling out 13.1 billion Japanese yen ($97 million) to secure a priority review voucher and speed up the regulatory timeline, the FDA extended its review just days before the drug’s prior regulatory decision date.

Vasomotor symptoms, or hot flashes and night sweats, are the hallmark of menopause. Some 60% to 80% of women experience the symptoms during or after menopausal transition, Astellas said in its release.

The drug's nonhormonal aspect is key because some people with menopause can’t take hormone therapies, the FDA said in its own statement.

Veozah treats menopause-related vasomotor symptoms by blocking a brain chemical called neurokinin B (NKB) which, along with estrogen, regulates the body’s temperature control center. When menopause begins, the balance is thrown off by declining estrogen levels.

“FDA approval of this new treatment for moderate to severe VMS due to menopause is a testament to Astellas' commitment to delivering innovative therapies in areas of unmet need that have been underserved, including women's health,” Astellas’ head of biopharma development Marci English said in the company’s statement.

The approval was supported by the results of three phase 3 trials, including a longer-term safety study, which showed the drug’s ability to prevent hot flashes. Its trial failure in Asia, in which Veozah failed to beat placebo, wasn’t included in the treatment’s application.