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Pfizer, Ligand snag FDA approval for hot flash drug

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Government shutdown or no, the FDA kept its PDUFA word for Pfizer ($PFE) and Ligand's ($LGND) treatment for hot flashes, approving a long-delayed drug that'll enter the crowded market for hormone therapies.

Duavee, formerly known as Aprela, combines estrogen conjugates with antagonist bazedoxifene to treat moderate-to-severe hot flashes in menopausal women who haven't had a hysterectomy. The drug is a holdover from Wyeth, which licensed it from Ligand years before Pfizer's 2009 buyout, and the hormone therapy has faced repeated setbacks, dealing with safety concerns and development delays that pushed its planned launch date by about 5 years.

And now, with little fanfare, it's ready to sell. Pfizer touts the drug as a hormone therapy with few of the side effects associated with similar treatments, but decade-old concerns about increased risk of breast cancer have largely tempered that market. And, as FiercePharma notes, Duavee's approval comes just four months after the FDA OKed Hisamitsu Pharmaceutical's Brisdelle, the first hormone-free treatment for hot flashes.

Despite a soft reception to the news, Ligand's shares have jumped about 7% since the announcement, and the approval means a $425,000 milestone payment for the company.

Perhaps the most interesting aspect of the Duavee approval is its confirmation that the FDA is keeping up its calendar despite a government shutdown. While mandatory furloughs have raided the agency of nearly half of its staff, activities funded by industry-paid user fees persist, including drug approvals and advisory committee meetings.

However, the shutdown prevents the FDA from collecting new fees and accepting NDAs, meaning that while any drugmaker with a scheduled agency date should be fine, a protracted congressional stalemate could halt approvals down the line.

- here's the FDA release
- read Pfizer's statement
- check out Ligand's announcement
- get more from FiercePharma

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