Pfizer drug for postmenopausal women accepted for EMA review

Pfizer has announced that bazedoxifene/conjugated oestrogens, its new therapy for postmenopausal women, has been accepted for European Medicines Agency (EMA) review.

The regulator will review the marketing authorisation application for the potential new product, which is indicated for the treatment of oestrogen deficiency symptoms and to help manage osteoporosis in women at risk of fracture.

Phase III clinical trials have produced positive safety and efficacy results for the drug, following studies involving around 7,500 patients.

A final decision from the European Commission is expected during 2013.

Steve Romano, senior vice-president and head of the medicines development group at Pfizer's primary care business unit, said: "This milestone is a further example of the company's commitment to advance treatments that may help improve health and wellbeing at each stage of life."

Last month, Pfizer reported data from a new clinical study of the innovative lung cancer treatment Xalkori that demonstrates its potential safety and efficacy.