Radiation illness drug fast-tracked
December 1, 2010
Cleveland BioLabs’ efforts to gain approval for its drug to combat radiation sickness got a further boost Tuesday when federal regulators granted it the status of orphan drug.
The designation means that the drug, Protectan, qualifies for an accelerated review process, along with tax credits, financial assistance with development costs and seven years of marketing exclusivity once it would receive approval from the U. S. Food and Drug Administration.
The designation also means that Cleveland BioLabs could qualify for an exemption from the FDA user fee and assistance in the protocol design for its clinical trials. Orphan drug status encourages the development of treatments for rare conditions.
Those clinical trials so far have shown that the drug can be effective if administered as long as 48 hours after initial exposure. Side effects were described as largely mild or moderate. Participants in a pair of human safety trials found that flulike symptoms — the most common — went away within 24 hours, according to Cleveland BioLabs executives.