FDA Announces Availability of Draft Guidance on Development of Anti-Rabies Virus Monoclonal Antibody Cocktails - Drug Information Update

If your email program has trouble displaying this email, view it as a web page. FDA Announces Availability of Draft GuidanceTitled Rabies: Developing Monoclonal Antibody Cocktails for the Passive Immunization Component of Post-Exposure Prophylaxis   The U.S. Food and Drug Administration is announcing the availability of a draft guidance for industry, Rabies: Developing Monoclonal Antibody Cocktails for the Passive Immunization Component of Post-Exposure Prophylaxis. The purpose of this guidance is to help sponsors in the development of anti-rabies virus monoclonal antibody (mAb) cocktails as the passive immunization component of post-exposure prophylaxis for rabies, as an alternative to anti-rabies virus immunoglobulin (RIG). Currently, RIG in combination with thorough wound washing and vaccination, is used to prevent rabies when given immediately after contact with a rabid or possibly rabid animal.  Rabies has an almost 100% case fatality rate after clinical symptoms develop and there is no proven treatment.   RIG is produced from the pooled serum of individuals hyperimmunized (induced to have the presence of larger than normal number of antibodies to a specific antigen) against the rabies virus, and currently is either of human (HRIG) or equine (ERIG) origin. In the United States, RIG is generally available; however, an alternative to RIG would be useful in case of RIG shortage and to eliminate the theoretical risk of transmission of blood-borne pathogens.   Development of mAbs for use in rabies PEP requires careful consideration of the risks and benefits, and should include an integrated assessment of data from nonclinical studies and clinical trials. FDA seeks comments and suggestions on this guidance 60 days after publication. For more information, please refer to the guidance.  This is an automated message delivery system. Replying to this message will not reach DDI staff. If you have comments or questions, please contact us at: 1-888-INFO- FDA (1-888-463-6332) or 301-796-3400 from 8:00 am - 4:30 pm ET Monday - Friday. You can also email us at: druginfo@fda.hhs.gov. Stay Connected with U.S. Food and Drug Administration:         SUBSCRIBER SERVICES: Manage Subscriptions  |  Unsubscribe All  |  Help

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