FDA approves Leukine for treating radiation in nuclear emergencies

The U.S. Food and Drug Administration (FDA) last week approved Leukine for use in adult and pediatric patients afflicted with Acute Radiation Syndrome, adding a third medical countermeasure to the nation’s stock for radiological and nuclear emergencies.

The drug counters myelosuppression — a suppression of the bone marrow which in turn blocks the production of blood cells. It is an effect of radiation damage. Leukine counters this by generating recovery of bone marrow cells, which in turn develop into white blood cells and help fight infections. In point of fact, the new countermeasure was found to increase survival chances even in those exposed to levels expected to be fatal in 50 percent of patients.

Leukine is effective so long as administered within 48 hours after total body irradiation, with minimal supportive care required. It does come with its small share of side effects, though: fever, injection site reactions and shortness of breath.

The drug was tested on animals under the FDA’s Animal Rule, which allows for the efficacy testing of animals when efficacy studies in humans cannot be conducted ethically. It had previously been approved in 1991 to shorten the time for neutrophil recovery and reducing the danger of infection following induction chemotherapy for leukemia.