DOR Obtains FDA’s Orphan Drug Designation For orBec

DOR has received FDA’s Orphan Drug Designation for Oral BDP (beclomethasone 17,21 dipropionate, or orBec). It is meant for the treatment of gastrointestinal (GI) symptoms associated with chronic Graft-versus-Host disease (cGVHD), in patients who have undergone allogeneic hematopoietic cell transplantation.

In addition to providing a seven-year term of market orBec upon final FDA approval, orphan drug designation also positions DOR to be able to take advantage of a range of financial and regulatory benefits. They include: government grants for conducting clinical trials, waiver of expensive FDA user fees for the potential submission of a New Drug Application for orBec, and certain tax credits.

Christopher Schaber, president and CEO of DOR, said: The FDA’s decision to grant orBec Orphan Drug Designation for the treatment of GI symptoms of cGVHD marks another step in the expansion of our orBec /oral BDP pipeline. Based on data we have already generated in the treatment of acute GI GVHD, we believe that orBec has the potential to be of significant benefit to cGVHD patients.

The US Orphan Drug Act is intended to assist and encourage companies to develop safe and effective therapies for the treatment of rare diseases and disorders.