May 1 Drugs from Amgen Inc, Teva
Pharmaceutical Industries and Sanofi that
boost white blood cells are being evaluated by U.S. regulators
as treatments for radiation exposure caused by a nuclear attack
The drugs, known as leukocyte growth factors, will be the
subject of a Friday meeting of an advisory committee to the U.S.
Food and Drug Administration.
Treatment with Amgen's Neupogen and Neulasta, Teva's
Tbo-filgrastim and Sanofi's Leukine, may decrease death rates
from radiation exposure, according to FDA staff documents
released ahead of the meeting.
Neupogen, which like the other drugs in the class is given
by injection, has been tested in monkeys exposed to radiation by
researchers at the National Institutes of Health and the
University of Maryland.
Friday's hearing was prompted by data from the trial showing
that the drug reduced mortality following lethal irradiation of
Amgen spokeswoman Ashleigh Koss said the company provided
additional nonclinical data from studies using the drugs in
radiation-exposed animals, and an overview of literature case
studies of their use in victims of radiological accidents.
She declined to comment on whether Amgen planned to
participate in any future trials of Neupogen or Neulasta as
treatments for radiation exposure.
The Amgen drugs, currently used to reduce the risk of
infection for cancer patients undergoing chemotherapy, had 2012
sales of $5.4 billion.