The US Food and Drug Administration has given the green light to Pfizer and Ligand Pharmaceuticals’ Duavee for menopausal symptoms.
Specifically the agency has approved Duavee (conjugated oestrogens/bazedoxifene; 0.45mg/20mg) tablets for the treatment of moderate-to-severe vasomotor symptoms (hot flushes) associated with menopause, and the prevention of postmenopausal osteoporosis. The approval is due in part to a Phase III study which demonstrated that the once-daily combo significantly reduced the number of moderate-to-severe hot flushes by 74% at 12 weeks compared with placebo (47%).
Another late-stage trial showed that at years one and two, Duavee significantly increased bone mineral density in the total hip and lumbar spine from baseline compared with decreases seen with placebo.
It is the only therapy to pair conjugated oestrogens with a selective oestrogen receptor modulator (SERM) and Pfizer notes that bazedoxifene was used instead of a progestin to help protect the uterine lining against hyperplasia that may result from oestrogen-alone treatment.
The drugs giant said it plans to launch Duavee in the first quarter of 2014. About 50% of US postmenopausal women experience moderate-to-severe hot flushes and Pfizer’s head of medical affairs, Gail Cawkwell, claimed the approval “presents a new opportunity for women and their doctors to discuss appropriate options”.
However, the FDA has also issued a complete response letter regarding a 0.625mg/20mg dose of Duavee. Pfizer noted that this was the only dose submitted for a proposed additional indication for vulvar and vaginal atrophy.
