FDA approves abaloparatide for osteoporosis patients resistant to available treatment

The Food and Drug Administration (FDA) has approved abaloparatide for the treatment osteoporosis among men at high risk for fracture or patients who are resistant or intolerant to other available osteoporosis therapy.

Osteoporosis-related fractures are an important health concern because of related morbidity, mortality, and cost.2 Bruce Mitlak, M.D., the Chief Medical Officer of Radius, emphasized that "30% of all hip fractures occur in men and approximately 25% of men over the age of 50 years will sustain an osteoporotic-related fracture. Additionally, while the overall prevalence of fragility fractures is higher in women, men generally have higher rates of fracture-related mortality."

"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.1 "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."

TYMLOS was approved in April 2017 for the treatment of postmenopausal women with osteoporosis at high risk for fracture, based on the Phase 3 ACTIVE study.1 Abaloparatide met the primary efficacy endpoint with a statistically significant relative risk reduction of new vertebral fracture at Month 18 versus placebo (0.6% versus 4.2%, respectively, p<0.0001). There was an 86% relative risk reduction in new vertebral fractures in postmenopausal women receiving abaloparatide versus placebo.

The most common adverse reactions (incidence ≥2%) reported with TYMLOS in men with osteoporosis are 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%).1 The most common adverse reactions (incidence ≥2%) reported with TYMLOS in postmenopausal women with osteoporosis are hypercalciuria (11%), dizziness (10%), nausea (8%), headache (8%), palpitations (5%), fatigue (3%), upper abdominal pain (3%), and vertigo (2%).1 Please see the detailed Important Safety Information provided below for more important safety information.

IMPORTANT SAFETY INFORMATION

Contraindications: TYMLOS is contraindicated in patients with a history of systemic hypersensitivity to abaloparatide or to any component of the product formulation. Reactions have included anaphylaxis, dyspnea, and urticaria.

Risk of Osteosarcoma: It is unknown whether TYMLOS will cause osteosarcoma in humans. Osteosarcoma has been reported in patients treated with a PTH-analog in the post marketing setting; however, an increased risk of osteosarcoma has not been observed in observational studies in humans. There are limited data assessing the risk of osteosarcoma beyond 2 years of TYMLOS use. Avoid use of TYMLOS for patients at an increased baseline risk for osteosarcoma including patients with open epiphysis (pediatric and young adult patients); metabolic bone diseases other than osteoporosis, including Paget's disease of the bone; bone metastases or a history of skeletal malignancies; prior external beam or implant radiation therapy involving the skeleton; or hereditary disorders predisposing to osteosarcoma.

Orthostatic Hypotension: Orthostatic hypotension may occur with TYMLOS, typically within 4 hours of injection. Associated symptoms may include dizziness, palpitations, tachycardia, or nausea, and may resolve by having the patient lie down. For the first several doses, TYMLOS should be administered where the patient can sit or lie down if necessary.

Hypercalcemia: TYMLOS may cause hypercalcemia. TYMLOS is not recommended in patients with pre-existing hypercalcemia or in patients who have an underlying hypercalcemic disorder, such as primary hyperparathyroidism, because of the possibility of exacerbating hypercalcemia.

Hypercalciuria and Urolithiasis: TYMLOS may cause hypercalciuria. It is unknown whether TYMLOS may exacerbate urolithiasis in patients with active or a history of urolithiasis. If active urolithiasis or pre-existing hypercalciuria is suspected, measurement of urinary calcium excretion should be considered.

Pregnancy and Lactation: TYMLOS is not indicated for use in females of reproductive potential.