Posted by Michael Wonder on 07 Jun 2018
Partner Therapeutics announces US FDA approval of Leukine (sargramostim) for the treatment of acute radiation syndrome
6 June 2018 - Partner Therapeutics announced the recent FDA approval of Leukine for the treatment of adult and paediatric patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome, or H-ARS).
Leukine is the first drug for H-ARS to demonstrate an improvement in survival when initiated 48 hours after radiation exposure.
Efficacy studies of Leukine could not be conducted in humans with acute radiation syndrome for ethical and feasibility reasons and approval of this use was based on government-sponsored efficacy studies conducted in animals.
