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The drugs, known as leukocyte growth factors, will be the subject of a Friday meeting of an advisory committee to the US 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 irradiation of the animals. Amgen spokesperson 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.
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 irradiation of the animals. Amgen spokesperson 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.
