OrBec
Generic name: beclomethasone dipropionate
Treatment for: Intestinal Graft-versus-Host Disease (iGVHD)
DOR BioPharma Plans FDA NDA and European MAA Filing Strategy for orBec
MIAMI, November 15, 2005 -- DOR BioPharma, Inc. (AMEX:DOR) ("DOR" or the "Company"), announced today that following written communications and meetings with the FDA and with the comparable regulatory authorities of the German, French and UK governments, it has established an expanded strategy for the submission of a New Drug Application (NDA) and Marketing Authorization Application (MAA) for orBec for the treatment of intestinal Graft-versus-Host disease ("iGVHD").
Following a meeting on November 1, 2005 with the Division of Drug Oncology Products at the FDA, DOR intends to submit the NDA for orBec in the United States in early 2006. On November 3rd, 4th and 7th, DOR met with the Bundesinstitut fur Arzneimittel und Medizinprodukte (BfArM) in Germany, the Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSaPS) in France, and the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK respectively. Based on these meetings, which followed submission of a pre-meeting package, DOR has determined to submit an MAA to the centralized European Agency for the Evaluation of Medicinal Products (EMEA) in the first half of 2006.
Michael T. Sember, President and CEO of DOR commented, "This was our first meeting with the Oncology Division following the transfer of reviewing responsibility from the Gastrointestinal Division. The meeting was very productive and provided DOR with valuable advice, particularly with regard to the Division's current weighting of the net clinical benefit of a product addressing an unmet medical condition such as iGVHD. The Division has informed us that the mortality results of the pivotal trial are of particular importance for their review of the NDA and they have asked for additional mortality information which we will provide. We were also very pleased with the cooperation and helpful advice of the European authorities and have thus decided to move ahead with the MAA filing ahead of our previous plans."
In conjunction with our plans for submission of the MAA in Europe, we have increased our commercial activities in Europe and are now in discussions with a number of parties regarding a potential licensing arrangement.
Posted: November 2005
Related articles
- DOR BioPharma Announces Results of orBec End of Review Conference with the FDA - December 7, 2007
- DOR BioPharma Receives Not Approvable Letter From FDA for orBec for Treatment of Gastrointestinal Graft-vs.-Host Disease - October 19, 2007
- DOR BioPharma, Inc. Announces 3 Month Extension of FDA PDUFA ActionDate for orBec New Drug Application to Review Supplemental Data - July 19, 2007
- DOR BioPharma Files New Drug Application with FDA to Market orBec for GI GVHD - September 22, 2006
- DOR BioPharma Provides Regulatory Update on orBec - June 30, 2006
- DOR BioPharma to File NDA for orBec - April 20, 2005
OrBec (beclomethasone dipropionate) FDA Approval History
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