NATALIZUMAB AND FDA

Natalizumab and FDA

Natalizumab and FDA

Introduction

Several companies have been investigating the potential of very late activation antigen-4 (VLA-4, also known as a4ß1 integrin), located on the surface of T cells, as a drug target in a variety of inflammatory diseases.

Prior to the FDA's March 2005 decision, the agency granted expedited approval of natalizumab in November 2004 for treatment of MS. Natalizumab was the first MS treatment to begin the approval process after one year of clinical trial data, and Biogen Idec and Elan submitted second-year data in the same month that the drug was approved. Analysts predicted that the drug ...