May 22, 2008 - DOR BioPharma, Inc., a late-stage biopharmaceutical company developing products to treat the life-threatening side effects of cancer treatments, serious gastrointestinal diseases and vaccines against certain bioterrorism agents, announced today that it has voluntarily withdrawn its European Marketing Authorization Application (MAA) for its investigational drug orBec® (oral beclomethasone dipropionate) for the treatment of gastrointestinal Graft-versus-Host disease (GI GVHD). DOR reached this decision after consultation with the European Medicines Evaluation Agency (EMEA) and is based on the assessment that confirmatory evidence of clinical efficacy will be required for approval, which is consistent with the request made by the US Food and Drug Administration (FDA) in their October 18, 2007 non-approvable letter. The withdrawal of an MAA application does not prejudice the possibility of DOR making a new application at a later stage. As part of DOR's ongoing European regulatory and development strategy, DOR has entered into a letter of intent for a Named Patient Program (NPP) for orBec® for the treatment of GI GVHD with IDIS, worldwide specialists in the management of NPPs. The NPP will allow DOR to ensure that patients with GI GVHD, an unmet medical need, can access orBec® legally and ethically.
The details can be read here.
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