May 22, 2015

New research leads to FDA approval of first drug to treat radiation sickness

As a result of research performed by scientists at the University of Maryland School of Medicine (UM SOM), the U.S. Food and Drug Administration has approved the use of a drug to treat the deleterious effects of radiation exposure following a nuclear incident. The drug, Neupogen®, is the first ever approved for the treatment of acute radiation injury.

The research was done by Thomas J. MacVittie, PhD, professor, and Ann M. Farese, MA, MS, assistant professor, both in the University of Maryland School of Medicine (UM SOM) Department of Radiation Oncology's Division of Translational Radiation Sciences. The investigators did their research in a non-human clinical model of high-dose radiation.

"Our research shows that this drug works to increase survival by protecting blood cells," said Dr. MacVittie, who is considered one of the nation's leading experts on radiation research. "That is a significant advancement, because the drug can now be used as a safe and effective treatment for the blood cell effects of severe radiation poisoning."

Radiation damages the bone marrow, and as a result decreases production of infection-fighting white blood cells. Neupogen® counteracts these effects. The drug, which is made by Amgen, Inc., was first approved in 1991 to treat cancer patients receiving chemotherapy. Although doctors may 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.

This planning is already under way. In 2013, the Biomedical Advanced Research and Development Authority (BARDA), an arm of the Department of Health and Human Services, bought $157 million worth of Neupogen® for stockpiles around the country in case of nuclear accident or attack.

Neupogen® is one of several "dual-use" drugs that are being examined for their potential use as countermeasures in nuclear incidents. These drugs have everyday medical uses, but also may be helpful in treating radiation-related illness in nuclear events. Dr. MacVittie and Ms. Farese are continuing their research on other dual-use countermeasures to radiation. They are now focusing on remedies for other aspects of radiation injury, including problems with the gastrointestinal tract and the lungs.

Please continue reading from: