Pfizer files Aprela at EMA for Oestrogen Deficiency Symptoms

The European Medicines Agency (EMA) accepted for review the Marketing Authorization Application (MAA) for bazedoxifene/conjugated estrogens (BZA/CE) from Pfizer, 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 in 2013. 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.