Tymlos Reduces Fracture Risk Through 3.5 Therapy Years in Phase 3 Trial

Tymlos, a recently FDA-approved human parathyroid hormone related peptide injection, showed a significant reduction in vertebral and nonvertebral bone fracture among postmenopausal women with osteoporosis after an extended 42-month trial, according to a press release from the treatment’s manufacturer.

“There is a substantial unmet medical need among postmenopausal women with osteoporosis at high risk of a fracture and we believe that these women deserve access to proper diagnosis and early intervention,” Lorraine Fitzpatrick, MD, chief medical officer at Radius Health, said in the press release. “Patients who have had a fracture are at a five-fold risk of a subsequent fracture and reducing fracture risk should be the goal of treatment.”

In the phase 3, double-blind, controlled ACTIVE trial, 2463 postmenopausal women with osteoporosis from multiple centers and countries were assigned to received 18 months of subcutaneous Tymlos injection (abaloparatide-SC; Radius). Those who completed the 18-month course were subsequently enrolled in ACTIVExtend, which continued the therapy open-label for an additional 24 months.

After 42 months, patients with continued treatment demonstrated an 84% relative risk reduction in the incidence of new vertebral fractures compared with those who received 18 months of placebo prior to initiating Tymlos (P < .0001), a 39% reduction in nonvertebral fracture risk ( P = .038), a 34% reduction in clinical fracture risk (P = .045), and a 50% reduction in major osteoporatic fracture risk (P = .011). Adverse event rates were similar between both arms of ACTIVExtend, and there were no cases of osteonecrosis of the jaw or atypical femoral fracture in any study group. 

“We are extremely pleased with the results of the landmark ACTIVExtend trial which provides physicians, payers, and patients with new insights into a treatment paradigm which targets building bone with an anabolic first line and then extending the benefit of fracture risk reduction with a low cost antiresorptive agent,” Bruce Mitlak, MD, vice president of clinical development at Radius Health said. 

Tymlos was approved by the FDA in  April. —Dave Muoio