Acute radiation syndrome comprises serious bone marrow, gastrointestinal, and other toxicities arising from exposure to high doses of radiation.
In order to qualify for orphan drug designation with the EMA, a drug must be intended for the treatment, prevention or diagnosis of a disease that is life-threatening or chronically debilitating; the prevalence of the condition in the EU must not be more than 5 in 10,000 people; no satisfactory method of diagnosis, prevention or treatment of the condition concerned can be authorized, or, if such a method exists, the medicine must be of significant benefit to those affected by the condition.
Sponsors who obtain orphan designation benefit from a number of incentives, including: protocol assistance, scientific advice, market exclusivity once the medicine is on the market, and reductions in certain fees.
Cleveland BioLabs CEO Yakov Kogan said: "We are excited to be initiating a regulatory process with the EMA for entolimod as a radiation countermeasure. We believe entolimod can offer an effective treatment for people who have been exposed to potentially life-threatening radiation as the result of a radiation accident or nuclear attack. We are dedicated to making the drug commercially available for the benefit of Europeans in case of a radiation emergency."
The US Food and Drug Administration previously granted orphan drug status to entolimod for prevention of death following a potentially lethal dose of total body irradiation during or after a radiation disaster.