Radius Health NDA for Osteoporosis Drug

Radius Health has submitted an NDA for abaloparatide-SC 80 mcg, an investigational, once daily treatment for postmenopausal women with osteoporosis. The submission is supported by data from an 18-month Phase 3 study called ACTIVE, which evaluated 2,463 postmenopausal women with osteoporosis. The company says the trial met primary and secondary endpoints, including the endpoint of reduction of vertebral fractures as well as key endpoints showing 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,” Radius says. If approved, abaloparatide-SC would be the first new bone anabolic treatment option in the U.S. since 2002. A Marketing Authorization Application was submitted 11/2014 that seeks approval for use in Europe.