Takeda asks FDA to OK its potential inflammatory bowel disease blockbuster

Takeda has taken another big step forward with one of its key late-stage drugs, filing for U.S. approval for vedolizumab as a new treatment for Crohn's disease and ulcerative colitis, the two most common forms of inflammatory bowel disease. The drug originally was plucked out of the inflammatory portfolio of Millennium Pharmaceuticals after the Japanese pharma company bought it for close to $9 billion.

In the spring of 2012 Takeda released two brief statements on vedolizumab (MLN0002), saying the drug produced a statistically significant rate of clinical remission for Crohn's disease and ulcerative colitis. But in the second Phase III CD trial the company had to concede that the drug failed a primary endpoint on enhanced response. No data were discussed.

Nevertheless, Takeda tapped it as one of 6 programs slated for approval in 2014, making it a key player in the big game to come up with fresh products to replace the Actos money being lost to generics. 

The antibody is an alpha-4 beta-7 integrin antagonist targeted at leukocytes and designed to shut down an inflammatory process that triggers Crohn's disease and ulcerative colitis. By aiming for the gut while avoiding interfering with the immune system, Takeda believes it has a safer approach to TNF-alpha blockers like Remicade and Humira. 

Decision Resources noted last fall that vedolizumab and Stelara were expected to help significantly grow these two blockbuster markets over the next 8 years. "Decision Resources anticipates that both agents will be primarily reserved for the TNF-refractory population, with vedolizumab achieving slightly greater uptake due to its earlier entry to the market and its potentially lower price."

"The disease burden of IBD is quite significant in the United States, especially on the many young adults living with Crohn's disease and ulcerative colitis," said Asit Parikh, M.D., Ph.D., vice president, general medicine, Takeda. "This regulatory submission marks a significant step forward for vedolizumab in the U.S., and as a company we are excited about the possibility of providing this community with a new treatment option."

- here's the press release