UM SOM study leads to FDA approval of Neulasta drug for treatment of radiation injury

Jan 21 2016

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.

"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.

With both drugs now approved, governments world-wide can more easily stockpile adequate amounts in case of emergency. The Federal government is already in the midst of this work. 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 incident.

Dr. MacVittie and his colleagues 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.

The research builds on 40 years of work that Dr. MacVittie and his team have conducted in the field of radiation research.

"The research team of Drs. MacVittie and Hankey and Prof. Farese has done exceptional work in this crucial area of public health research," said Dean E. Albert Reece, MD, PhD, MBA, who is also the vice president for Medical Affairs, University of Maryland, and the John Z. and Akiko K. Bowers Distinguished Professor and Dean of the School of Medicine. "This research not only links the bench to the bedside; it goes beyond that, and will have important benefits for our national security and that of our allies around the world."

SOURCE University of Maryland School of Medicine