The Food and Drug Administration cleared the drug, Duavee, for moderate-to-severe hot flashes related to menopause in women who haven’t had a hysterectomy, the agency said today in a statement. The medicine, also approved to prevent post-menopausal osteoporosis, will be available in the first quarter of 2014, Pfizer said today in a statement.
The medicine from Pfizer, the world’s biggest drugmaker, will enter a market for hot-flash treatments that includes Hisamitsu Pharmaceutical Co. (4530)’s Brisdelle. Eli Lilly & Co. (LLY:US)’s Evista, which generated $1 billion in sales last year, was approved in 1997 for prevention of post-menopausal osteoporosis. Duavee is the first FDA approved medicine that combines estrogen with a compound that selects certain tissues to work on.
Duavee contains the ingredient bazedoxifene that can act like estrogen on bone to protect density combined with a mixture of estrogens. Pfizer, based in New York, sells Premarin, which generated $1 billion in sales last year and is derived from the urine of pregnant horses. Premarin has six uses, including the two Duavee will be labeled to treat.
Ligand rose (LGND:US) 7 percent to $47.99 at the close in New York, it’s biggest gain in more than three months. Pfizer fell less than 1 percent to $28.77.
The most common side effects of Duavee in clinical trials were muscle spasms, nausea, diarrhea, and abdominal pain, among others, the FDA said.
Ligand, based in La Jolla, California, formed a research deal with Pfizer-acquired Wyeth, which developed the medicine. The FDA rejected bazedoxifene in 2009, after multiple delays, as an osteoporosis treatment on stroke and clotting concerns.
Duavee will have the same boxed warning as other estrogen products, the FDA said. Premarin warns against an increased risk of cancer of the uterus and of dementia.
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