US FDA approves first drug for radiation exposure
23 May 2015
The US Food and Drug Administration (FDA) has approved a drug originally used to treat side effects of chemotherapy, to treat the deleterious effects of radiation exposure following a nuclear incident.
Neupogen has become the first drug to be approved for the treatment of acute radiation injury, approval for which has come after research by the University of Maryland School of Medicine (UM SOM) scientists.
The research was conducted by investigators in a non-human clinical model of high-dose radiation.
According to Thomas MacVittie, one of the researchers, the research showed that the drug worked to increase survival by protecting blood cells.
He noted that was a significant advancement, as the drug could now be used as a safe and effective treatment for the blood cell effects of severe radiation poisoning.
Radiation causes bone marrow damage, consequently it decreases production of infection-fighting white blood cells. Neupogen works against these effects.
The drug, made by Amgen Inc, was first approved in 1991 to treat cancer patients receiving chemotherapy.
According to the study although doctors might use it "off label" for other indications, the research and the resulting approval would speed up access to and use of the drug in the event of a nuclear incident, according to the study.
Neupogen is one of several "dual-use" drugs under investigation for their potential use as countermeasures in nuclear incidents.
Dual-use drugs had everyday medical uses, but might also be helpful in the treatment of radiation-related illness in nuclear events.
The researchers are continuing their research on other dual-use counter-measures to radiation and are now focusing on remedies for other aspects of radiation injury, including problems with the gastrointestinal tract and the lungs.
The Neupogen study formed a broad portfolio of research being conducted by faculty in the Department of Radiation Oncology.
Among these were Minesh Mehta, MD, the medical director of the Maryland Proton Treatment Center, whose work focused on research into thoracic oncology, neuro-oncology, integrating imaging advances with radiation therapy, as also innovative applications of new radiation therapy technologies to test biological concepts.
