Radius Reveals FDA Acceptance For Filing Of NDA For Abaloparatide-SC For Treatment Of Postmenopausal Women With Osteoporosis

Radius Health, Inc. RDUS revealed that the FDA has accepted its New Drug Application (NDA) for abaloparatide–SC. According to the company, the acceptance of the NDA reflected the regulator's determination that the application was sufficiently complete to permit a substantive review.

Radius Health said the NDA was supported by data from the complete abaloparatide-SC development program. That included the results from the 18-month Phase 3 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.

The company added that positive results for abaloparatide-SC treatment groups from the ACTIVE and ACTIVExtend studies have met the primary, as well as, the secondary endpoints essential for submission of the NDA. That included the primary endpoint of reduction of vertebral fractures and key endpoints of reduction of nonvertebral, clinical, and major osteoporotic fractures. In these and the other studies 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 Health President and CEO, Robert Ward, commented, "The FDA's acceptance for filing of our abaloparatide-SC NDA is a major milestone for Radius and we look forward to continuing to work with the FDA as they review our application. Given the high unmet medical need in osteoporosis, we believe that abaloparatide-SC, if approved, has the potential to become a promising new treatment option for the approximately 10 million postmenopausal women with osteoporosis, many of whom remain untreated."

The company indicated that Abaloparatide-SC was an investigational treatment for postmenopausal women with osteoporosis and its safety and efficacy were not established.

On Tuesday, the stock advanced 4.11 percent.