BioMimetic Therapeutics receives orphan drug designation for osteochondritis dissecans treatment

BioMimetic Therapeutics, Inc. announced that it has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for its protein therapeutic, recombinant human platelet derived growth factor (rhPDGF-BB), to be used in conjunction with autograft and/or commercially available osteochondral allograft for the treatment of osteochondritis dissecans (OCD) of the knee, elbow or ankle.

Orphan drug status, designated to drugs that have the potential to treat rare diseases, provides an accelerated path to FDA approval and may provide 7 years of market exclusivity, the company noted in a press release. The designation was enacted by the FDA to encourage the development of therapeutic products for clinical indications that affect fewer than 200,000 individuals in the United States. In addition to the possible marketing exclusivity from the date of drug approval, drugs that receive orphan drug designation obtain tax credits for clinical investigation costs, marketing application filing fee waivers and assistance from the FDA in the drug development process. Orphan drug designation does require a clinical trial to gain market approval authorization through the New Drug Application (NDA) process.

“We are fortunate that our rhPDGF-BB platform technology has the opportunity to improve healing across a broad array of injuries. In sports medicine, we’ve had a robust product development program for some time evaluating product candidates for tendon, ligament and cartilage repair. This orphan designation should facilitate this work in the cartilage area,” Samuel Lynch, DMD, DMSc, president and CEO of BioMimetic Therapeutics, stated in the release. “OCD can be a severely painful joint disorder for which there is a lack of consensus on an optimal therapeutic treatment. Surgery is often required, but rarely completely alleviates the disorder.”