EMA to review Pfizer MAA for bazedoxifene/conjugated estrogens

BZA/CE is designed for postmenopausal women with a uterus for the treatment of estrogen deficiency symptoms and osteoporosis in women at risk of fracture.

The company said BZA/CE has been studied in a Phase III Selective estrogens, Menopause And Response to Therapy (SMART) trials which enrolled approximately 7,500 postmenopausal women to assess the safety and efficacy of BZA/CE.

The common adverse drug reactions observed in the SMART trials were abdominal pain, vaginal yeast infection and muscle spasms.

Pfizer senior vice president and primary care business unit medicines development group head Steve Romano said the company is pleased to be one step closer to potentially bringing BZA/CE to women to help manage symptoms of menopause.

"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," Romano added.

Pfizer said it is expecting a decision from the European Commission in 2013.