Press Release Details
Radius’ Abaloparatide Receives Positive CHMP Opinion for the Treatment of Osteoporosis in Postmenopausal Women at Increased Risk of Fracture
Cambridge, Mass., October 14, 2022 – Radius Health, Inc. (“Radius” or the “Company”) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization for ELADYNOS® (abaloparatide), a parathyroid hormone related peptide [PTHrP(1 34)] analogue, to treat osteoporosis in postmenopausal women at increased risk of fracture. Abaloparatide has been approved in the United States (US) since April 2017 under the tradename of TYMLOS.
“We are very excited and thankful for the CHMP positive opinion received less than 1 year after submitting the Marketing Authorization Application via the Centralized Procedure,” said Colleen Davenport, Vice President of Regulatory Affairs for Radius Health. “This is important for patients as osteoporosis leads to increased risk of fragility fractures which are associated with substantial pain and suffering, disability, and even death. Abaloparatide decreases risk of fracture by increasing new bone formation on trabecular and cortical bone surfaces by stimulating osteoblastic activity.”
“Radius is committed to advancing bone health in patients globally,” said Chhaya Shah, Chief Business Officer for Radius Health. “With this positive opinion and anticipated approval, we will be able to provide abaloparatide to postmenopausal women with osteoporosis in the EU who are at increased risk for fracture and eventually to more patients worldwide.”
The decision from the CHMP for ELADYNOS is based on data from a Phase 3 multicenter, double-blind, placebo- and open-label active comparator-controlled (teriparatide) clinical study in postmenopausal women with osteoporosis and additional supporting data including a prospectively planned, retrospective observational cohort study using US claims data from more than 22,000 patients. A decision authorizing marketing approval in the EU by the European Commission, based on the CHMP recommendation, is expected later this year.
Radius is a global biopharmaceutical company focused on addressing unmet medical needs in the areas of bone health and oncology. Radius’ lead product, 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. The Radius clinical pipeline includes investigational abaloparatide injection for potential use in the treatment of men with osteoporosis and the investigational drug, elacestrant (RAD1901), for potential use in the treatment of hormone-receptor positive breast cancer out-licensed to Menarini Group.
Abaloparatide (TYMLOS®) was approved by the U.S. Food and Drug Administration as indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, TYMLOS reduces the risk of vertebral fractures and nonvertebral fractures.
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.
Adverse Reactions: The most common adverse reactions (incidence ≥2%) reported with TYMLOS are hypercalciuria, dizziness, nausea, headache, palpitations, fatigue, upper abdominal pain, and vertigo.
Please see full Prescribing Information, including Medication Guide, available at TymlosPI.com.
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