FDA Is Considering Approval for Drugs to Improve Survival after Nuclear Attack
With the amount of news coverage spent on North Korea earlier this spring, you may have believed that you were in the midst of the Cold War all over again. Seemingly as a result, the Food and Drug Administration is considering approving two drugs that have been found to improve survival in the wake of a nuclear attack.
According to Bloomberg, the drugs in question are Neulasta and Neupogen, both of which are produced by Amgen, and a third blood-boasting drug produced by Teva Pharmaceutical Industries.
The Food and Drug Administration made this announcement after the National Institute of Allergy and Infectious Diseases performed a study as part of its program to develop countermeasures against radiation and nuclear attack.
The participants in the NIH study were monkeys, who were all exposed to radiation in levels that would be about equivalent to those created by an attack. The monkeys had to remain in these conditions for 60 days. Of the 46 monkeys, 24 of them were given Neupogen, while the remaining 22 were given nothing. Of the monkeys who were administered Neupogen, 79 percent survived for the entire trial period. Among the 22 monkeys who received nothing, only 41 percent survived.
The medications in question are called leukocyte growth factors. Currently, they have been approved for use in cancer patients whose infection-fighting white blood cell counts are low after chemotherapy treatments. Both of Amgen's treatments, as well as the treatment from Teva, are made up of synthetic material that replicates a protein in the body which spurs bone marrow to create white blood cells.
As Fierce Pharma reports, if the drugs are approved for this purpose, it would be the first time that the FDA had approved medical treatment to be used after a nuclear incident. In fact, even the consideration is a first by the drug agency.
"The FDA-approval of a product for use in a radiological [or] nuclear setting will facilitate access to this product in the event of such an emergency," the FDA said in a report.
The agency is meeting on Friday in order to discuss whether the animal trial merits its approval in humans.