FDA Accepts Radius Health NDA for Osteoporosis Therapy

FDA has accepted for review a Radius Health NDA for abaloparatide-SC, indicated for treating postmenopausal women with osteoporosis. The submission is supported by data from an 18-month Phase 3 trial called ACTIVE, which evaluated 2,463 postmenopausal women with osteoporosis. It also includes data from the first six months of the ACTIVExtend trial, involving 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,” Radius says. Abaloparatide is a novel synthetic peptide that engages the parathyroid hormone receptor (PTH1 receptor) and was selected for clinical development based on its favorable bone building activity, it says.