BioCentury
ARTICLE | Company News

FDA reviewing Radius' abaloparatide

June 2, 2016 12:56 AM UTC

Radius Health Inc. (NASDAQ:RDUS) said FDA accepted for review its NDA for abaloparatide-SC (BA-058-SC) to treat osteoporosis in postmenopausal women. Spokesperson Lori Gorski told BioCentury that FDA has yet to provide Radius with the candidate's PDUFA date.

An MAA for the subcutaneous peptide analog of parathyroid hormone-related protein (PTHrP) is under EMA review. Radius had hoped to submit the NDA by YE15, but delayed the submission until March to include 12-month stability data for the candidate. EMA had required only six-month stability data (see BioCentury Extra, Nov. 17, 2015). ...