FDA releases BioMimetic briefing documents

FDA released briefing documents in advance of Tuesday's advisory committee meeting about BioMimetic's application for its GEM 21S product to treat bone defects of the jaw in patients with advanced periodontal disease, as well as other cranio-maxillofacial (CMF) indications. FDA did not release an evaluation of the application.

GEM 21S, which is being regulated as a device, is a combination of platelet-derived growth factor BB ( rhPDGF-BB) and a resorbable synthetic bone matrix. Both elements of the GEM 21S are marketed by other companies as stand-alone products. BioMimetic obtains the rhPDGF-BB used in the GEM 21S from Chiron (CHIR), which markets it as Regranex becaplermin to treat diabetic foot ulcers. ...