FDA Delays Review of Abaloparatide-SC for Postmenopausal Osteoporosis

Agency needs more time to evaluate synthetic peptide

The FDA has informed Radius Health that it will require additional time to complete its review of the company’s new drug application (NDA) for abaloparatide-SC. The agency extended the Prescription Drug User Fee Act (PDUFA) action date to June 30, 2017. In its letter, the FDA did not request any additional information from Radius.

Abaloparatide is an investigational therapy for the potential treatment of women with postmenopausal osteoporosis who are at an increased risk of fracture. Abaloparatide is a synthetic peptide that engages the parathyroid hormone 1 (PTH1) receptor. It was selected for clinical development based on its bone-building activity.

Abaloparatide has completed phase 3 development for potential use as a daily self-administered subcutaneous injection. Radius submitted its NDA for abaloparatide-SC to the FDA at the end of the first quarter of 2016.

In August 2016, Radius Health reported positive results from the phase 3 Abaloparatide Comparator Trial In Vertebral Endpoints (ACTIVE). The study evaluated the safety and efficacy of abaloparatide-SC in the treatment of 2,463 postmenopausal women with osteoporosis. Patients treated with daily abaloparatide-SC for 18 months showed a significantly greater reduction in the incidence of new vertebral fractures (P < 0.001) and nonvertebral fractures (P = 0.049) compared with placebo.

Radius Health also is developing abaloparatide-transdermal (abaloparatide-TD) based on 3M’s patented microstructured transdermal system (MTS) technology for potential use as a treatment for patients with osteoporosis.

Sources: Radius Health; March 10, 2017; and Radius Health; August 16, 2016.