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Research out of University of Maryland School of Medicine leads to FDA approval for radiation sickness drug

Press releases may be edited for formatting or style
BALTIMORE, Jan. 20, 2016 /PRNewswire-USNewswire/ -- 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 (FDA) has approved the use of a drug to treat the deleterious effects of radiation exposure following a nuclear incident. The drug, Neulasta®, is one of a very small number that have been approved for the treatment of acute radiation injury.

The research was done by Thomas J. MacVittie, PhD, professor, and Kim Hankey, PhD, Study Director, both in the Preclinical Radiobiology Laboratory at the University of Maryland School of Medicine Department of Radiation Oncology's Division of Translational Radiation Sciences (DTRS). The investigators did their research in a non-human clinical model of high-dose radiation. Ann M. Farese, MA, MS, assistant professor in the same lab and department, also contributed to the work.

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"This is further evidence of how the University of Maryland School of Medicine has led and will continue to lead the way in radiation science research," said Zeljko Vujaskovic MD, PhD, an internationally-recognized physician scientist and Professor of Radiation Oncology at UM SOM who directs the Division. "We look forward to strong future growth and expansion in this area."

Currently there are the only two drugs that have been approved by the FDA to treat people exposed to potentially lethal doses of radiation from a nuclear incident or attack: Neulasta® and Neupogen®, which was approved earlier this year. The key studies leading to the approval of Neupogen were also conducted by Dr. MacVittie and his colleagues.

"This approval is very gratifying. Our work found that Neulasta was effective at protecting blood cells," said Dr. MacVittie, who is an expert on radiation research. "This means we now have two excellent options to combat blood cell problems that occur with severe radiation poisoning."

Radiation damages the bone marrow, and as a result decreases production of infection-fighting white blood cells. Drugs such as Neupogen and Neulasta counteract these effects. Both drugs are made by Amgen, Inc.

Neupogen was first approved in 1991 to treat cancer patients receiving chemotherapy. Although doctors may use both drugs "off label" for other indications, the research and the resulting approval would speed up access to and use of the drugs in the event of a nuclear incident.

Both Neulasta and Neupogen have the same mechanism of action. Neupogen must be administered daily for as long as three weeks. An advantage of Neulasta is that it has a longer lasting effect, and thus needs to be administered only once a week for two weeks.
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