US FDA approves first drug to treat radiation injuries

Saturday, May 23, 2015,18:36 IST By metrovaartha A A A

New York | The US health watchdog FDA 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 approval by the US Food and Drug Administration (FDA) came as a result of a research done by Professor Thomas J MacVittie and Assistant Professor Ann M Farese of University of Maryland School of Medicine. The research was held in a non-human clinical model of high-dose radiation.
Our research shows that this drug works to increase survival by protecting blood cells, MacVittie said. 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, he added.
Neupogen is the first FDA-approved medical countermeasure to increase survival in patients exposed to myelosuppressive doses of radiation, a statement by FDA had earlier said. It was approved by FDA based on studies in animals (under the Animal Rule), as studies in humans could not be ethically conducted, it added. Radiation damages the bone marrow, and as a result decreases production of infection-fighting white blood cells. Neupogencounteracts 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, the study said. 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 USD 157 million worth of Neupogen for stockpiles around the country in case of nuclear accident or attack.
The research builds on 40 years of work that Dr MacVittie and his team have conducted in the field of radiation research, during which they have helped to define the field. The Neupogen study is part of a broad portfolio of research being conducted by faculty in the Department of Radiation Oncology.