BioCentury
ARTICLE | Clinical News

Radius preparing NDA, MAA for osteoporosis treatment

June 19, 2015 1:19 AM UTC

Radius Health Inc. (NASDAQ:RDUS) gained $7.91 (15%) to $59.64 after it released six-month top-line data from the ACTIVExtend extension study and from a combined analysis of ACTIVExtend and the Phase III ACTIVE study of abaloparatide-SC ( BA058-SC) to prevent fractures in postmenopausal women with severe osteoporosis. The company said it believes the compound has met all primary and secondary endpoints required for submissions this year of an NDA to FDA and an MAA to EMA.

The 24-month extension study, which spokesperson Barbara Ryan said does not have a primary endpoint, evaluated patients receiving alendronate, a standard of care therapy for maintenance of osteoporosis, following treatment with abaloparatide-SC or placebo in ACTIVE. Radius CEO Robert Ward said the extension study was designed around a "build and maintain" treatment cycle; the 18-month ACTIVE trial would evaluate efficacy of the bone-building treatment, and the ACTIVExtend trial would determine if those effects were maintained during a standard of care regimen. Radius said that in the first six months of ACTIVExtend there were no new vertebral fractures in patients who had previously taken abaloparatide, compared to six in patients who had previously taken placebo (p<0.0001). ...