FDA Accepts Emergent’s sBLA for Manufacturing of its Anthrax Vaccine

June 20, 2016

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 press announcement. Emergent is seeking approval for the manufacture of BioThrax in Building 55, the company’s large-scale manufacturing facility.

“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 orphan drug status, guaranteeing its protection until 2022. The drug is currently the only vaccine licensed for distribution and immunization in the United States for the treatment of anthrax exposure. 

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.

Source: Emergent BioSolutions