FDA approves acute radiation injury drug

Chuck Bednar for redOrbit.com – @BednarChuck

The US Food and Drug Administration approved the first ever drug for use in treatment of acute radiation injury, thanks in part to research led by scientists at the University of Maryland School of Medicine that evaluated the medication using a non-human clinical model.

The drug is called Neupogen, and it treats the effects of post-nuclear incident radiation exposure, the university explained in a statement. The trials were led by Dr. Thomas J. MacVittie and Ann M. Farese from the UM Department of Radiation Oncology’s Division of Translational Radiation Sciences, who conducted their research using models involving high-dose radiation.

“Our research shows that this drug works to increase survival by protecting blood cells,” said Dr. MacVittie, a professor at the school and purportedly one of the nation’s leading experts in the field of 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.”

Research called scientifically important, essential to public health

Exposure to radiation damages bone marrow and decreases production of infection-fighting white blood cells in the body, but the researchers claim that taking Neupogen counters these symptoms. The drug, manufactured by Amgen Inc., was originally approved for use in cancer patients receiving chemotherapy in 1991.

The approval will allow doctors to prescribe Neupogen for other reasons and speed up access to the drug in the case of a nuclear incident, they added. The US Biomedical Advanced Research and Development Authority (BARDA) already ordered more than $150 million of the drug to stockpile throughout the US in case of a nuclear attack or accident.

Dr. MacVittie and his colleagues have been working in the field of radiation research for more than four decades, and the team now plans to continue their work by evaluating other “dual use” drugs that could be used to treat radiation poisoning. They are currently focusing on remedies for radiation-induced illnesses of the gastrointestinal tract and the lungs.

“The Department of Radiation Oncology’s work is just one example of how the School of Medicine is discovering innovative ways to repurpose existing drugs that are able to fight a broader array of critical diseases,” department dean Dr. E. Albert Reece said, adding that the Neupogen research is “not only important scientifically” but also “crucial for our country’s public health and its national security.”


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