Developing Rabies Monoclonal Antibody Cocktail Guidance

FDA has issued a draft guidance, Rabies: Developing Monoclonal Antibody Cocktails for the Passive Immunization Component of Post-Exposure Prophylaxis, to help sponsors develop such cocktails as an alternative to anti-rabies virus immunoglobulin as the passive immunization component of post-exposure prophylaxis for the prevention of rabies when given immediately after contact with a rabid or possibly rabid animal. The document is intended to serve as a focus for continued discussion among the Division of Antivirals, sponsors, the academic community, and the public, FDA says. It does not address the development of rabies vaccines, products to treat rabies, or monoclonal antibodies for other indications.

The draft includes Introduction, Background, Development Program (general considerations, Phase 3 efficacy trial considerations, other considerations), and References.