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US FDA Looks For Advisory Panel's Blessing Of Development Pathway For Monoclonal Antibodies In Rabies PEP

 
• By Michael Cipriano

FDA's Division of Antiviral Products proposes a pathway for sponsors to develop monoclonal antibodies designed for rabies post-exposure prophylaxis as an alternative to anti-rabies virus immunoglobulin, but it wants input from an advisory committee before proceeding.

FDA Advisory Committee Feature image

The US Food and Drug Administration has devised a development pathway to support the approval of monoclonal antibodies for use in rabies post-exposure prophylaxis (PEP) as an alternative to anti-rabies virus immunoglobulin (RIG), and now the agency is looking for a blessing from its Antimicrobial Drugs Advisory Committee.

The committee will convene 25 April to provide its input on whether the components of the FDA's proposed approach are acceptable, including the information needed to initiate clinical studies, the necessary clinical data to support a biologics license application (BLA)

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