Press Release Details
European Commission Approves ELADYNOS (Abaloparatide) for the Treatment of Osteoporosis in Postmenopausal Women at Increased Risk of Fracture
Cambridge, Mass., December 19, 2022 – Radius Health, Inc. (“Radius” or the “Company”) announced that the European Commission has granted marketing authorization for abaloparatide under the tradename of ELADYNOS 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. Abaloparatide is a PTHrP (1-34) analog that stimulates new bone formation on trabecular and cortical bone surfaces by stimulation of osteoblastic activity leading to a reduction of new fractures. Abaloparatide is supplied as a single-patient multi-use prefilled pen designed to administer 80 micrograms per dose over a 30-day period.
Chhaya Shah, Chief Business Officer of Radius, said, “We are pleased by the European Commission’s approval to bring additional treatments to postmenopausal women with osteoporosis who are at high risk for fracture living in the European Union. This is important for patients because osteoporosis leads to increased risk of fragility fractures which are associated with substantial pain and suffering, disability, and even death.”
The EU approval of ELADYNOS is based on data from the pivotal Phase 3 multicenter, double-blind, placebo- and open-label active comparator-controlled (teriparatide) clinical study in postmenopausal women with osteoporosis (ACTIVE Study, BA058-05-003), its two-year extension study (BA058-05-005), and additional supporting data including a prospectively planned, retrospective observational cohort study using US claims data from more than 22,000 patients.
“Because the use of Real-World-Evidence in supporting regulatory decision making can be very challenging, Radius sought National Scientific Advice from 8 countries in the EU to discuss how to best prospectively design such a study,” said Colleen Davenport, Vice President of Regulatory Affairs at Radius. “Data from this study supported the noninferiority of abaloparatide to teriparatide in the prevention of nonvertebral fractures and similar safety in patients treated with abaloparatide or teriparatide.”
The European Commission marketing authorization approval is valid in all EU Member States as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway. Abaloparatide is now approved in 32 countries, including the US and Japan.
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 is a synthetic 34 amino acid peptide that shares 41% homology to parathyroid hormone [PTH(1-34)] and 76% homology to parathyroid hormone related peptide [PTHrP(1 34)], and is an activator of the PTH1 receptor signaling pathway. Abaloparatide stimulates new bone formation on trabecular and cortical bone surfaces by stimulation of osteoblastic activity.
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.
Phone: (617) 583-2017