FDA approves sBLA for BioThrax

The FDA has approved Emergent BioSolution's sBLA for BioThrax, the company's anthrax vaccine. The new approval changes the number of total vaccinnations that must be administered. It now calls for five intramuscular doses of BioThrax at 0, 1, 6, 12 and 18 months, compared with the former schedule of six subcutaneous doses at 0, 2 weeks and 1, 6, 12, 18 months. Emergent said the CDC is still studying whether even fewer doses of the drug could be equally effective. When that data becomes available in 2009, Emergent may submite another sBLA to further reduce the number of required BioThrax injections.

"Today's announcement is an exciting milestone in our continued mission to advance BioThrax. We are pleased that the U.S. Government shares our commitment to enhancing this critical countermeasure. The CDC is to be applauded for their hard work and diligence throughout this important effort," said Emergent's president and COO Daniel Abdun-Nabi.

- here's Emergent's release

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