Crucell’s Rabies Antibody Cocktail Granted Fast-Track Status

The FDA has granted fast-track status to Dutch biotechnology company Crucell’s rabies monoclonal antibody cocktail.

Crucell is developing the rabies antibody cocktail for the post-exposure prophylaxis of rabies. The antibody cocktail is a combination of two human monoclonal antibodies and is produced using the company’s MAbstract and PER.C6 technologies.

The company said it has contracted with DSM Biologics for the process validation and manufacturing of antibody batches for Phase III efficacy studies.