Radius Health, Inc. (“Radius” or the “Company”) (NASDAQ: RDUS) today announced that the U.S. Food and Drug Administration (FDA) has approved updates to the Tymlos label, including the removal of the boxed warning regarding the risk of osteosarcoma.
The removal of the boxed warning comes after a thorough regulatory review of long-term post-marketing data in Tymlos and the parathyroid hormone (PTH) class of drugs. Additional labeling revisions include updates to the Warnings and Precautions section about the risk of osteosarcoma (see Important Safety Information below).
Bruce Mitlak, M.D., the Chief Medical Officer of Radius, commented, “This is an important update to the Tymlos label. Achieving this result was made possible by FDA analysis of a significant amount of data that had been generated over many years.” Dr. Mitlak continued, “This action and subsequent label change will provide both physicians and their patients with valuable information regarding individual treatment decisions.”
“This was a tremendous effort by the Radius team in working with the FDA to obtain approval to remove the boxed warning regarding the risk of osteosarcoma,” added Chhaya Shah, Senior Vice President, who leads the clinical and regulatory activities for abaloparatide. Shah continued, “We remain focused on exploring additional label adjustment opportunities for Tymlos and, in that regard, maintain an ongoing dialogue with the FDA around additional data.”
About Radius
Radius Health is a global biopharmaceutical company focused on addressing unmet medical needs in the areas of bone health, neuroscience, and oncology. Our team works collaboratively and relentlessly to advance our therapies; all with the goal of improving the lives of patients, their families, and their caregivers. The Radius portfolio consists of commercial and clinical development assets, including early to late-stage drug candidates. Find out more at www.radiuspharm.com.
About Tymlos (abaloparatide) injection
Tymlos (abaloparatide) injection was approved by the U.S. Food and Drug Administration for the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.
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 e...
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