Radius Health (RDUS) Announces Publication of Positive Phase 3 ACTIVE Data in JAMA
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Radius Health, Inc. (Nasdaq: RDUS) announced that positive results from the Phase 3 ACTIVE (Abaloparatide Comparator Trial In Vertebral Endpoints) trial were published in the Journal of the American Medical Association (JAMA). This landmark trial enrolled 2,463 patients to evaluate the safety and efficacy of investigational drug abaloparatide for the treatment of postmenopausal women with osteoporosis. The ACTIVE results showed that patients treated with daily abaloparatide for 18 months had a significantly greater reduction in the incidence of new vertebral fractures (p < 0.001) and nonvertebral fractures (p = 0.049) compared to placebo.
“The landmark ACTIVE trial results are important and further validate abaloparatide’s potential to consistently, substantially and rapidly reduce both new vertebral and nonvertebral fractures in postmenopausal women with osteoporosis,” said Dr. Paul Miller, Medical Director at the Colorado Center for Bone Research and lead author of the paper. “Approximately two million osteoporotic fractures occur annually in the U.S., which create physical and psychological burdens for affected women by diminishing their independence and quality of life. There is a great unmet medical need for therapies which could provide more consistent potent and early benefits to patients.”
“We are honored to have these findings published in JAMA, and are encouraged by the totality of data collected to date which demonstrate that abaloparatide, if approved, could have a significant impact in improving outcomes for women with postmenopausal osteoporosis,” said Dr. Lorraine A. Fitzpatrick, Chief Medical Officer of Radius. “We look forward to presenting additional scientific information about abaloparatide as part of the American Society for Bone Mineral Research (ASBMR) Annual Meeting in Atlanta, Georgia September 16-19, 2016.”
Abaloparatide is an investigational treatment for postmenopausal women with osteoporosis and its safety and efficacy have not been established. A New Drug Application for abaloparatide is currently under review by the U.S. Food & Drug Administration.
Access the online JAMA manuscript: http://jama.jamanetwork.com/article.aspx?doi=10.1001/jama.2016.11136
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