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NEW YORK — Pfizer Inc. has received Food and Drug Administration approval for Duavee, a medication for menopause and related conditions.
The drug maker said Thursday that Duavee tablets (conjugated estrogens/bazedoxifene, 0.45 mg/20 mg) are indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause and the prevention of postmenopausal osteoporosis, for women with a uterus.
Pfizer reported that research shows an estimated 50% of postmenopausal women experience moderate to severe vasomotor symptoms, commonly known as hot flashes.
"We know that many women currently experiencing menopausal symptoms are not receiving treatment and have not talked to their doctor about hormone therapy. It is clear that the menopause dialogue needs to improve," stated Gail Cawkwell, vice president for Pfizer Medical Affairs. "The approval of Duavee, an important, novel and effective treatment, presents a new opportunity for women and their doctors to discuss appropriate options for managing hot flashes and preventing osteoporosis."
The FDA approval is the first clearance for Duavee in any country worldwide, according to Pfizer. The company expects to ship the product in the United States in the first quarter of 2014.
Duavee was developed by Wyeth Pharmaceuticals, a subsidiary of Pfizer, and is part of a broader research collaboration with Ligand Pharmaceuticals Inc.
"We believe this is an important achievement in the field of women’s medicine, a therapy area in which Ligand has had a rich history of research," commented John Higgins, president and chief executive officer of Ligand. "There has been a significant therapeutic need for additional safe and effective medicines to improve health and well-being for women, and we commend the Duavee team at Pfizer for their commitment and leadership in driving this medicine to regulatory success. We are extremely pleased by the decision by the FDA, and we look forward to the launch of Duavee."
