Crucell’s rabies antibody receives Fast Track designation

The Fast Track designation allows for frequent communications with the FDA and the possibility of submitting portions of the marketing application (a BLA) before the complete BLA is submitted.

The first-in-man Phase I study, which was conducted in the US and started in January 2007, indicated that the cocktail is well tolerated, provides the expected neutralizing activity and that it can be safely co-administered in combination with a standard rabies vaccine.

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 it is produced with the use of Crucell’s MAbstract and PER.C6 technologies.

Jaap Goudsmit, chief scientific officer of Crucell, said: “We are very pleased to receive the Fast Track designation for our rabies antibody cocktail. Given the unmet medical need in rabies we are committed to moving as fast as possible. This designation along with its allowance of frequent interaction with the FDA and possible priority review mechanisms clearly signal the importance of expanding rabies treatment availability.”