Announced by Radius Health on December 20, the US FDA approval for abaloparatide (Tymlos) indicates the agent as a treatment to increase bone density in men with osteoporosis at high risk of fracture or in patients who have failed or are intolerant to other available osteoporosis therapy.
The US Food and Drug Administration (FDA) has approved abaloparatide (Tymlos) as a treatment for osteoporosis in men at high risk for fracture.
Announced by Radius Health Inc. statement on December 20, the approval, which is based on results of the phase 3 ATOM study, indicates the parathyroid hormone related peptide for increasing bone density in men with osteoporosis at high risk of fracture or in patients who have failed or are intolerant to other available osteoporosis therapies.
“TYMLOS has been helping postmenopausal women with osteoporosis at high risk for fracture for over five years. We are excited that with this approval, we can bring TYMLOS to a new population,” said Chhaya Shah, Chief Business Officer at Radius, in the aforementioned statement. “We are grateful to the men who participated in the ATOM study, as they played a pivotal role in helping bring this important treatment to men with osteoporosis at high risk of fracture.”
A randomized, double-blind, placebo-controlled, 12-month multicenter trial, the Abaloparatide Treatment of Men (ATOM) study was designed to determine the efficacy and safety of abaloparatide 80 micrograms in men with osteoporosis and were announced in October 2022. With a primary efficacy endpoint of the percent change from baseline in bone mineral density at the lumbar spine at 12 months, results of the study demonstrated use of abaloparatide was associated with a mean increase in BMD of 8.5% compared to 1.2% among patients receiving the placebo.
Abaloparatide had previously received approval from the FDA for treatment of postmenopausal women with osteoporosis at high risk for fracture based on the phase 3 ACTIVE study in April 2017. In the ACTIVE trial, use of abaloparatide was associated with a statistically significant 86% relative risk reduction of new vertebral fracture at 18 months compared against placebo therapy (P <.0001).
“Radius stands behind our commitment to the bone health community and with this approval, men with osteoporosis at high risk for fracture will have an additional important treatment option,” added Scott Briggs, Chief Executive Officer at Radius.
In the aforementioned statement, Radius Health noted the most common adverse reactions reported with abaloparatide in men with osteoporosis were injection site erythema (13%), dizziness (9%), arthralgia (7%), injection site swelling (7%), injection site pain (6%), contusion (3%), abdominal distention (3%), diarrhea (3%), nausea (3%), abdominal pain (2%), and bone pain (2%). In postmenopausal women, the most common adverse reactions were hypercalciuria (11%), dizziness (10%), nausea (8%), headache (8%), palpitations (5%), fatigue (3%), upper abdominal pain (3%), and vertigo (2%).