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Emergent drug gets coveted FDA status

Emergent BioSolutions Inc., of Rockville, which develops and manufactures products that harness the immune system to treat and prevent disease, announced its BioThrax treatment for anthrax disease has been granted orphan drug status by the Food and Drug Administration for people with suspected or confirmed exposure to anthrax.

BioThrax, the only FDA-licensed anti-anthrax vaccine, is currently licensed for pre-exposure to anthrax spores.

The orphan drug designation— conferred on drugs that are aimed at rare conditions that lack treatment therapies — gives Emergent a range of incentives while developing the post-exposure candidate, including seven years of market exclusivity following FDA approval, FDA assistance in clinical trial design, a reduction in FDA user fees and tax credits.