DOR's orBec gets not-approvable from FDA

USA-based DOR BioPharma has received a "not approvable" letter from the Food and Drug Administration for its lead product orBec (oral beclomethasone dipropionate) for the treatment of acute gastrointestinal graft-versus-host disease, a common and potentially life-threatening complication of hematopoietic cell transplantation. The FDA has requested data from additional clinical trials to demonstrate the safety and efficacy of the agent. Additionally, the agency has asked for information with respect to other sections of the New Drug Application.

Christopher Schaber, chief executive of DOR, said: "while we were hoping for a nearer term approval for orBec given the clinical effect we believe we demonstrated in our two randomized, double-blind, placebo-controlled trials, we firmly believe in the pharmacology of orBec and its potential to help address the overwhelming need for a safe and effective treatment for patients suffering from GI GVHD."