DOR BioPharma files NDA for orBec to treat graft-versus-host disease

By E. Janene Geiss

Philadelphia, Sept. 22 - DOR BioPharma, Inc. said Friday that it has submitted a New Drug Application to the Food and Drug Administration to market orBec (oral beclomethasone dipropionate) for the treatment of gastrointestinal graft-versus-host disease, the most common life-threatening complication of allogeneic hematopoetic stem cell transplantation.

The drug is a two-pill system containing the highly potent topically active corticosteroid beclomethasone dipropionate designed to specifically target and treat upper and lower gastrointestinal graft-versus-host disease with reduced systemic immunosuppressive side effects, the Miami biopharmaceutical company said in a news release.

Systemic immunosuppressive agents, such as prednisone, that are currently the standard treatment for gastrointestinal graft-versus-host disease are associated with high rates of mortality due to infection and debility.

OrBec has previously been granted fast-track designation for gastrointestinal graft-versus-host disease by the FDA and thus may qualify for priority review, officials said.

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