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news.The European Medicines Agency (EMA) has validated to review Radius Health's Marketing Authorization Application (MAA) for abaloparatide subcutaneous (SC) to treat osteoporosis in postmenopausal women.
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With this validation, the Radius application is complete and now under review by the EMA.
Radius Health president and CEO Robert Ward said: "The MAA for abaloparatide-SC is based on the results from the ACTIVE and ACTIVExtend trials, which demonstrated significant clinical benefit for postmenopausal women at risk of osteoporotic fracture.
"The acceptance of our application for review by the EMA represents a significant step towards potentially bringing abaloparatide-SC to postmenopausal women with osteoporosis in Europe, and Radius looks forward to working with the EMA in the review procedure."
The MAA submission is based on the final results of the 18 month ACTIVE and the first 6 months of the ACTIVExtend trials in osteoporosis.
The clinical trials demonstrated that once daily abaloparatide-SC reduced the risk of vertebral and nonvertebral fractures as compared to placebo.
The MAA for the investigational abaloparatide-SC was submitted in Europe on November 17, 2015 and the company plans to submit a New Drug Application (NDA) to the US Food and Drug Administration (FDA) by the end of the first quarter of 2016.
This week Radius initiated the human pharmacokinetic (PK) clinical evaluation of the optimized abaloparatide transdermal patch (TD) based upon 3M’s Microstructured Transdermal System technology with the goal of achieving comparability to abaloparatide subcutaneous injection (SC).
This human "replicative" study is intended to confirm in healthy postmenopausal women the pharmacokinetic profile of the transdermal patch as established in primate studies. Radius will use the results from this replicative study to inform the design of the registration program.
About the Investigational Drug Abaloparatide
Abaloparatide is an investigational agent and has not been approved by the FDA or the EMA.
Abaloparatide is a novel synthetic peptide that interacts with the human parathyroid receptor 1 that we are developing as a bone anabolic treatment for potential use in the reduction of osteoporotic fracture risk in postmenopausal women.
Abaloparatide-SC is an investigational drug currently completing Phase 3 development for potential use as a daily self-administered injection for the potential treatment of patients with postmenopausal osteoporosis at risk of fracture.
Radius also is developing the investigational drug abaloparatide-TD for potential use as a short wear-time transdermal patch designed to administer abaloparatide based on 3M’s patented Microstructured Transdermal System technology.
The Phase 3 ACTIVE study evaluated abaloparatide, teriparatide and placebo in postmenopausal women at risk of osteoporotic fracture. The results were presented as a late-breaker at the Endocrine Society Annual Meeting (ENDO) in March 2015 and in an oral presentation at the American Society of Bone and Mineral Research Meeting (ASBMR 2015) in October 2015.
The Phase 3 ACTIVExtend results were presented as a plenary oral presentation at the American Society of Bone and Mineral Research (ASBMR) in October 2015.
Radius previously reported preliminary, nonhuman primate pharmacokinetic studies of abaloparatide-TD which showed that a desirable pharmacokinetic profile was achieved with comparable AUC, Cmax, Tmax and T1/2 relative to abaloparatide-SC. These results were presented at the 2015 Annual Meeting of the American Society of Bone and Mineral Research.