Takeda Pharmaceuticals USA Inc. announced that a Biologics License Application (BLA) has been submitted to the United States (U.S.) Food and Drug Administration (FDA) for vedolizumab, an investigational humanized monoclonal antibody for the treatment of adults with moderately to severely active Crohn’s disease (CD) and ulcerative colitis (UC), the two most common types of inflammatory bowel disease (IBD).
Vedolizumab is a monoclonal antibody being developed by Millennium Pharmaceuticals, Inc. for the treatment of ulcerative colitis and Crohn’s disease. It binds to integrin α4β7 (LPAM-1, lymphocyte Peyer’s patch adhesion molecule 1).
The cell line was discovered by Dr. Andrew Lazarovits and Dr. Robert Colvin as the murine MLN0002 homologue. Their discovery of the mouse equivalent of this antibody—originally applied to anti-rejection strategies in kidney transplantation—was published in the journal Nature, in 1996. The research was conducted at Massachusetts General Hospital in Boston, MA. Dr. Lazarovits and Dr. Colvin’s cell line was subsequently licensed to Millennium Pharmaceuticals of Boston for further development.