European Medicines Agency accepts regulatory submission for bazedoxifene/conjugated estrogens
Posted: 19 July 2012 | | No comments yet
The EMA has accepted for review the MAA for bazedoxifene/conjugated estrogens…
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 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.
“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.”
Menopause is a normal, natural event – it marks the permanent end of fertility and is usually confirmed when a woman has missed her period for 12 consecutive months (in the absence of other obvious causes). Menopause is associated with reduced functioning of the ovaries due to aging, resulting in lower levels of estrogen and other hormones. In the European Union, an estimated 67 million women are of menopausal age. Of those, approximately 75% suffer from hot flashes.
Osteoporosis is a disease of the bones that leads to an increased risk of fracture. Decreased estrogen levels are associated with rapid bone loss, making women more susceptible to osteoporosis. Osteoporosis is estimated to affect up to a fifth of women in Europe between the ages of 50 and 79.
About the Ligand/Pfizer Collaboration
BZA/CE was developed by Wyeth and was part of a broader research collaboration with Ligand Pharmaceuticals Incorporated on SERMs. Pfizer acquired the rights to BZA/CE when it acquired Wyeth. Under the terms of the agreement, Ligand receives certain payments and royalties from Pfizer on predetermined development and sales milestones.