BA 058 (abaloparatide-SC) filed with FDA for osteoporosis- Radius Health

Radius Health has submitted a New Drug Application (NDA) to the FDA for BA 058 (abaloparatide–SC) 80 mcg an investigational, once daily treatment for postmenopausal women with osteoporosis. The NDA is supported by data from the entire abaloparatide-SC development program, including the results from the 18-month Phase III ACTIVE trial in 2,463 postmenopausal women with osteoporosis and the first six months of the ACTIVExtend trial in 1,139 of the ACTIVE participants. Positive results for abaloparatide-SC treatment groups from the ACTIVE and ACTIVExtend trials have met the primary and secondary endpoints essential for submission of the NDA, including the primary endpoint of reduction of vertebral fractures as well as key endpoints of reduction of nonvertebral, clinical, and major osteoporotic fractures. In these and the other trials submitted in the NDA, abaloparatide-SC administered at a dose of 80 mcg daily was generally safe and well tolerated in postmenopausal women with osteoporosis.

Comment: Radius Health submitted a Marketing Authorisation Application (MAA) for the investigational drug abaloparatide-SC in Europe on November 17, 2015, which is currently undergoing regulatory review. If approved, abaloparatide-SC would be the first new bone anabolic treatment option in Europe since 2003 and the first in the U.S. since 2002 for postmenopausal women with osteoporosis.