Pfizer Inc. (NYSE: PFE) today announced that the European Medicines
Agency (EMA) accepted for review the Marketing Authorization Application
(MAA) for bazedoxifene/conjugated estrogens (BZA/CE), a potential new
medicine for postmenopausal women with a uterus for the treatment of
estrogen deficiency symptoms and treatment of osteoporosis in women at
risk of fracture. Pfizer expects a decision from the European Commission
BZA/CE pairs the selective estrogen receptor modulator (SERM)
bazedoxifene with conjugated estrogens. BZA/CE has been studied in a
Phase III clinical development program (Selective estrogens, Menopause
And Response to Therapy [SMART] trials) which
included approximately 7,500 postmenopausal women and assessed the
safety and efficacy of BZA/CE for the treatment of estrogen deficiency
symptoms, such as moderate-to-severe hot flashes and vulvar and vaginal
atrophy, as well as postmenopausal osteoporosis. The most common adverse
drug reactions observed in the SMART trials were abdominal pain, vaginal
yeast infection and muscle spasms.
"We are pleased to be one step closer to potentially bringing
bazedoxifene/conjugated estrogens to women to help manage symptoms of
menopause," said Steve Romano, senior vice president, Head of the
Medicines Development Group in Pfizer's Primary Care Business Unit.
"This milestone is a further example of the company's commitment to
advance treatments that may help improve health and well-being at each
stage of life."