FDA accepts NDA filings from Pfizer/Ligand and Actelion; Bayer submits Alpharadin

The US Food and Drug Administration accepted for review a New Drug Application from pharma behemoth Pfizer (NYSE: PFE) and partner Ligand Pharmaceuticals (Nasdaq: LGND) for bazedoxifene/conjugated estrogens (BZA/CE), a potential new medicine for non-hysterectomized women for the treatment of moderate-to-severe vasomotor symptoms (VMS) and vulvar and vaginal atrophy (VVA) associated with menopause, as well as the prevention of postmenopausal osteoporosis. The FDA Prescription Drug User Fee Act (PDUFA) date is October 3, 2013.

BZA/CE pairs the selective estrogen receptor modulator (SERM) bazedoxifene with conjugated estrogens. The product 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 moderate-to-severe VMS and VVA associated with menopause, as well as the prevention of postmenopausal osteoporosis. The most common adverse drug reactions observed in the SMART trials were abdominal pain, vaginal yeast infection and muscle spasms.

Gail Cawkwell, vice president, Pfizer’s Medical Affairs, said: “BZA/CE was developed for non-hysterectomized women with moderate-to-severe menopausal symptoms. This milestone moves us one step closer towards potentially providing the first new treatment option in the US in years for the treatment of these women’s menopausal symptoms.”