Anti-radiation medicine climbs another rung on the FDA ladder

Dec 2, 2010

Buffalo-based drug maker Cleveland Biolabs has been working on a medicine to protect against radiation poisoning for more than seven years. And this week the drug, CBLB502, took another step towards approval by the Food and Drug Administration.

If the FDA’s approval process is a ladder, the medicine’s recent designation as an “orphan drug” is another rung on the climb to marketing the exclusive formula. But the medicine still faces more than a year of scrutiny and development before the FDA ultimately decides whether the medicine is fit for sale.

The orphan drug designation will cut Cleveland Biolabs a break on development costs, through financial assistance, tax breaks, and exclusive market rights for seven years if the drug is approved.

If the medicine is approved by the FDA, CBLB502 will likely get a new, catchier name. Yet despite its clunky moniker, the medicine has been attracting special attention, and orders to stock the drug (for the Strategic National Stockpile), from several government agencies. That’s because the medical need it serves currently has no remedy.

CBLB502 has been designed to aid the recovery from exposure to radiation, making it useful for lessening the effects of cancer treatment, or for recovering from exposure after a nuclear attack. Seeing potential in the yet-to-be-approved drug, the Department of Defense has already placed an order for nearly 40,000 units of the medicine.

“We’re developing this drug for several potential buyers. [The Department of Defense] is of course a very important buyer. But we’re also working closely with another large potential government buyer in the United States which would be the Department of Health and Human Services. And I think everyone is looking to see the next step,” said Rachel Levine, director of corporate development for Cleveland Biolabs.

Orders for the drug are expected to climb into the millions if the FDA gives the medicine a green light. Allies to the United States have already expressed interest in ordering the drug if it passes through all proper hurdles.

“We’re certainly eager to see what happens [with orders for the stockpile] as far as radiation [treatment] goes. There are no approved drugs for this indication currently available. And we do hope that we will be the first there. And we believe that could potentially have some implications as far as the national stockpile goes,” Levine said.

A final decision on approval is expected before mid-2012.