US FDA Looks For Advisory Panel's Blessing Of Development Pathway For Monoclonal Antibodies In Rabies PEP
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.
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A second-line indication for rabies post-exposure prophylaxis is the best a monoclonal antibody can initially expect, but postmarketing studies could get the product upgraded to first-line status, the Antimicrobial Drugs Advisory Committee suggests as it endorses the US FDA's proposed development plan in two separate 16-0 votes.
Serum Institute has launched a cut-price oral thermostable rotavirus vaccine in India, but competitors like Hilleman Labs, also developing a heat-stable vaccine in the area, aren’t losing much sleep, for now at least. Serum has also introduced a rabies monoclonal antibody.