US FDA backs Pfizer’s hot flashes drug Duavee

US pharma behemoth Pfizer (NYSE: PFE) and partner Ligand Pharmaceuticals (Nasdaq: LGND) said late Thursday say that the US Food and Drug Administration has approved Duavee (conjugated estrogens/bazedoxifene) 0.45mg/20mg tablets, a novel therapy for women with a uterus, for the treatment of moderate-to-severe vasomotor symptoms associated with menopause and the prevention of postmenopausal osteoporosis.

Under the terms of a license agreement with Pfizer, Ligand has earned a $425,000 milestone payment for the approval. Ligand shares jumped 7% to $47.99 at the close if New York trading, its biggest gain in more than three months, while Pfizer dipped less than 1% to $28.77.

Duavee will enter a market for hot-flash treatments that includes Hisamitsu Pharmaceutical’s (TYO: 4530) Brisdelle (paroxetine 7.5mg) and Eli Lilly’s (YSE: LLY) Evista (raloxifene); the latter generated $1 billion in sales last year and was approved in 1997 for prevention of post-menopausal osteoporosis, reported Bloomberg.