Radius Health announced the submission of a New Drug Application (NDA) to the Food and Drug Administration (FDA) for abaloparatide-subcutaneous (SC) 80mg, a once daily treatment for postmenopausal women with osteoporosis.
The NDA submission is based on data from the abaloparatide-SC development program that included findings from the 18-month Phase 3 ACTIVE trial (n=2,463) in postmenopausal women with osteoporosis. Data from the first 6 months of the ACTIVExtend Trial (n=1,139) was also included.
Positive data showed that patients treated with abaloparatide-SC in both trials met the primary and secondary endpoints. The primary endpoint was reduction of vertebral fractures and other key endpoints included reductions of non-vertebral, clinical, and major osteoporotic fractures. Abaloparatide-SC administered at 80mcg daily was generally safe and well tolerated in study patients.
Abaloparatide, a novel synthetic peptide, engages the parathyroid hormone receptor (PTH1 receptor) and was selected for clinical development based on its favorable bone building activity. It is being studied for potential as a daily, self-administered injection.
If approved by the FDA, abaloparatide-SC will be the first new bone anabolic in the United States since 2002.
For more information visit RadiusPharm.com.