Pfizer and Ligand Pharmaceuticals have announced the FDA acceptance of bazedoxifene/conjugated estrogens (BZA/CE) new drug application (NDA) for review.
The BZA/CE is an investigational therapy developed by Wyeth Pharmaceuticals to tackle symptoms such as vasomotor symptoms and vulvar and vaginal atrophy associated with menopause and for prevention of osteoporosis in non-hysterectomized women.
Pfizer's medical affairs vice president Gail Cawkwell said BZA/CE was developed for the sake of non-hysterectomized women exhibiting moderate-to-severe menopausal symptoms.
"This milestone moves us one step closer towards potentially providing the first new treatment option in the U.S. in years for the treatment of these women's menopausal symptoms," Cawkwell added.
BZA/CE demonstrated considerable safety and efficacy profile in Phase III clinical development program conducted in 7,500 postmenopausal patients.
Ligand president and chief executive officer John Higgins said, "Pfizer continues to make good progress with this program, with this NDA submission shortly following the European Marketing Authorization Application submission earlier this year."
