Medications known as leukocyte growth factors, which also include Sanofi (SAN)’s Leukine, may help decrease death rates from radiation exposure, Food and Drug Administration staff said today in a report. FDA staff reviewed a National Institutes of Health study on monkeys exposed to radiation that were given Neupogen. Agency advisers plan to meet May 3 to discuss whether the animal study is sufficient to approve the use for humans.
This is the first time an FDA advisory committee will consider a medical countermeasure for use in a radiological or nuclear incident, the staff said. Neulasta, Amgen’s second best-selling drug, and Neupogen together generated about $5.4 billion in sales last year for the Thousand Oaks, California-based company, according to data compiled by Bloomberg. The drugs are given by injections.
“The FDA-approval of a product for use in a radiological/nuclear setting will facilitate access to this product in the event of such an emergency,” FDA staff said in the report.
The National Institute of Allergy and Infectious Diseases runs a program to develop radiation and nuclear countermeasures.
Of the 24 monkeys that took Neupogen in the NIH study, 79 percent survived after 60 days, compared with 41 percent of the 22 monkeys who didn’t take the drug, FDA staff said. NIH stopped the trial after studying 46 animals because of the comparison.
The drugs are currently used by cancer patients to boost infection-fighting white blood cells lowered by chemotherapy treatments. Amgen’s treatments and the product from Petach Tikva, Israel-based Teva are filgrastims, which the American Cancer Society says is a man-made version of a protein in the body that stimulates the bone marrow to make white blood cells.
Amgen shares rose less than 1 percent to $104.54 at 4 p.m. New York time.
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