Here's a story that takes us back to our Cold War childhood. Two of Amgen's ($AMGN) blockbuster blood drugs, Neulasta and Neupogen, may help victims survive after a nuclear attack, FDA staff reviewers say. An agency advisory panel meets later this week to discuss new animal study data--and consider whether the drugs should be approved for that use in humans.
As Bloomberg reports, it will be the first time the agency's expert advisers consider medical treatment for use in case of a nuclear incident. "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 wrote in their report in advance of the meeting.
The animal study, conducted by the National Institutes of Health, looked at Neupogen's use in 46 monkeys. Of the 24 given Neupogen, 79% survived after 60 days, Bloomberg says. Only 41% of the 22 who didn't take the drug survived.
The drugs are among Amgen's best sellers, and together brought in about $5.4 billion last year. Similar drugs from Teva Pharmaceutical Industries ($TEVA) and Sanofi ($SNY) like Leukine are also available.
Our question is this: If the FDA adds this new approval to one or more of the blood treatments, then would governments stockpile emergency supplies? In the wake of 9/11, there was a lot of talk about a "dirty bomb" attack in the U.S., which could expose thousands of people to intense radiation. And then there's the ongoing nuclear escalation in the Middle East and Asia.
- see the FDA staff report (PDF)
- read the Bloomberg piece
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