Home > About BNE > Press Room > 2010 Archive > December > FDA acts on BioLabs' drug product

FDA acts on BioLabs' drug product

Business First - by Tracey Drury

Date: Tuesday, November 30, 2010

Cleveland BioLabs Inc. has received orphan drug status for its CBLB502 product by the U.S. Food and Drug Administration.
The drug was granted approval for prevention of death following a potentially lethal dose of total body irradiation during or after a radiation disaster.

Designation as an orphan drug allows the company to pursue an accelerated review process, tax credits, financial assistance for development costs and seven years of marketing exclusivity upon approval by the FDA for the indication. The designation also allows for a possible exemption from the FDA-user fee and assistance in clinical trial protocol design.

Orphan status is awarded to drugs and biologics defined as those intended for the safe and effective treatment, diagnosis, or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 people but are not expected to recover the costs of developing and marketing the treatment.

The designation follows FDA’s granting in July of fast track status for the drug for the purpose of reducing the risk of death following total body irradiation during or after radiation disaster. There is currently no FDA approved medical countermeasure for this indication.

Development of the drug continues abroad as well: In October, the company received a notice of grant of patent from the State Intellectual Property Office of the People’s Republic of China.

Originally founded in Cleveland, the company (NASDAQ: CBLI) has offices in downtown Buffalo at the Buffalo Niagara Medical Campus, and has strategic partnerships with the Cleveland Clinic, Roswell Park Cancer Institute, ChemBridge Corp. and the Armed Forces Radiobiology Research Institute.