FDA Approves Radius Health’s Tymlos to Treat Osteoporosis

On April 28, 2017 Radius Health announced that FDA approved its bone building agent for the treatment of postmenopausal women with osteoporosis. Tymlos (abaloparatide), an injectable treatment for osteoporotic women with high risk for fracture, works by reducing the risk for vertebral and nonvertebral fractures. According to a press release from the company, Tymlos is the first anabolic bone building agent for postmenopausal women with osteoporosis approved in the United States in approximately 15 years.

In a conference call detailing the company’s first quarter financial results, Robert Ward, president and CEO of Radius Health, said the company expects Tymlos to “achieve blockbuster status.” The drug is expected to directly compete with Eli Lilly's Forteo (teriparatide) and Amgen's Prolia (denosumab).

During clinical trials, Tymlos demonstrated reduction in the risk of vertebral and nonvertebral fractures regardless of age, years since menopause, presence or absence of prior fracture (vertebral or nonvertebral), and bone mineral density (BMD) at baseline, the company said in a press release. In human clinical studies, Tymlos has been shown to decrease the incidence of new vertebral and nonvertebral fractures, to increase BMD, and to increase a marker of bone formation.