FDA approves Sanofi reject as new treatment for acute radiation syndrome

On March 29, the US Food and Drug Administration announced it has approved use of Leukine (sargramostim) to increase survival in adult and pediatric patients acutely exposed to myelosuppressive doses of radiation (hematopoietic syndrome of acute radiation syndrome, or H-ARS).

Boston, USA-based cancer start-up company  Partner Therapeutics (PTx) acquired the global rights to develop, manufacture and commercialize Leukine from French pharma major Sanofi (Euronext: SAN) on February 1 this year. The FDA filing for approval of this new indication was made before the change of ownership for the agent, presumably by Sanofi’s Genzyme unit, which was developing Leukine for the treatment of acute radiation syndrome, though the FDA approval notification did not state the name of the applicant.

Leukine was shown to increase survival when administered up to 48 hours after total body irradiation exposure at doses expected to be fatal to 50% of those exposed subjects under conditions of minimal supportive care.