Rabies Monoclonal Antibody Development Plan Gets US FDA Panel Backing
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.
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Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
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.
After US FDA's Oncologic Drugs Advisory Committee voted to delay approval of Karyopharm's multiple myeloma drug Xpovio, the company submitted some data from the Phase III BOSTON trial, which prompted the FDA to award an accelerated approval for a narrower indication.