FDA Clears Tymlos for Osteoporosis in Men

The FDA has approved Radius Health’s Tymlos (abaloparatide), a parathyroid hormone related peptide analog, to increase bone density in men with osteoporosis at high risk of fracture. It was approved in April 2017 for postmenopausal women with osteoporosis.

Bruce Mitlak, M.D.

“Thirty percent of all hip fractures occur in men and approximately 25% of men over the age of 50 years will sustain an osteoporotic-related fracture,” Bruce Mitlak, M.D., chief medical officer of Radius, said in a press release. “Additionally, while the overall prevalence of fragility fractures is higher in women, men generally have higher rates of fracture-related mortality

This approval is based on the phase 3 ATOM study, a 12-month multicenter study designed to evaluate the efficacy and safety of abaloparatide 80 micrograms in men with osteoporosis.

The primary efficacy endpoint of the ATOM study was the percent change from baseline in bone mineral density (BMD) at the lumbar spine at 12 months, which was 8.5% in the Tymlos compared with 1.2% in the placebo group. In the study, 228 men were enrolled.

The most common treatment emergent adverse events were injection site reaction, dizziness, nasopharyngitis, arthralgia, bronchitis, hypertension, and headache. The results were published Oct. 3, 2022, in the Journal of Bone and Mineral Research.

Radius Health announced in June 2022 that it the company is being acquired by Gurnet Point Capital and Patient Square Capital in a transaction valued at about $890 million, including the assumption of debt. Radius will become a private company when completed.