Cleveland BioLabs’ Entolimod wins orphan drug status from EMA as radiation countermeasure

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.