
FDA Accepts Emergent’s sBLA for Manufacturing of its Anthrax Vaccine
Emergent is seeking approval for the manufacture of BioThrax at the company’s large-scale manufacturing facility.
Emergent BioSolutions’s supplemental biologics license application (sBLA) for the manufacture of its anthrax vaccine, BioThrax, has been accepted for review by FDA, the company said in a June 17, 2016
“Emergent’s large-scale manufacturing facility, intended to increase the manufacturing capacity for BioThrax to an estimated 20 to 25 million doses annually, is a response to the US government’s desire to stockpile 75 million doses of a licensed anthrax vaccine,” said Adam Havey, executive vice-president and president, biodefense division at Emergent BioSolutions, in a press announcement.
BioThrax is indicated for pre-exposure and post-exposure prophylaxis of anthrax disease. FDA recently granted BioThrax
Emergent submitted the sBLA for BioThrax’s manufacture on April 15, 2016 and FDA has set a target action date of August 15, 2016. The company also noted the sBLA is supported by data demonstrating the manufacture of BioThrax at a large-scale is comparable to its current manufacturing procedures.
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