FDA approves new injectable drug for treatment of high-risk postmenopausal women with osteoporosis

IOF welcomes new drug option, giving high risk patients a greater choice among several effective therapies.

On April 28th, the U.S. Food and Drug Administration (FDA) approved Abaloparatide, a new osteoanabolic agent for the treatment of postmenopausal women with osteoporosis who are at high risk for fracture — patients who have had a prior osteoporotic fracture, have multiple fracture risk factors, or have failed or cannot tolerate other osteoporosis therapies.

Given as a daily, subcutaneous injection, the drug was shown in the ACTIVE clinical trial to reduce the relative risk of new vertebral and nonvertebral fractures compared to placebo by 86% and 43% respectively. The absolute risk reductions were 3.6% and 2.0%, respectively.

Fractures due to osteoporosis are a major cause of pain, disability, loss of quality of life and early mortality. High risk patients stand to benefit with every new effective and safe treatment option available – giving them greater choice in finding appropriate medication to meet their specific needs.

IOF President Professor Cyrus Cooper welcomed the addition of a new therapeutic option, stating:

This represents a major step forward in providing much needed therapy for our patients with osteoporosis.”