The FDA granted the designation because infection with shigatoxin-producing bacteria may result in hemolytic uremic syndrome, a serious condition for which there are no currently available preventative therapies.
The company anticipates moving Shigamabs into a pivotal phase II/III trial by the first quarter of 2007.
The fast track designation should expedite the regulatory process and may result in the drug reaching market more quickly. The designation means that the candidate could be eligible for priority review of the biologics license application (BLA), submitting portions of the BLA prior to completion of the entire application, and accelerated approvals.
An important feature of the fast track designation is to emphasize the close and early communication between the FDA and the company to improve the efficiency of product development.
“We are pleased with the fast track designation for Shigamabs,” stated Dr Marc Riviere, Caprion’s executive vice-president of clinical development. “Based on our clinical results to date, we believe that Shigamabs is a well-positioned candidate to become the first therapy for this significant unmet medical need.”