Takeda applies for approval of ulcerative colitis, Crohn's disease drug
DEERFIELD, Ill. — Takeda Pharmaceutical Co. is seeking Food and Drug Administration approval for an experimental treatment for inflammatory bowel disease, the drug maker said.
Takeda announced that it had submitted a biologics license application to the FDA for vedolizumab in patients with severe Crohn's disease and ulcerative colitis. IBD is estimated to affect more than 4 million people worldwide, and ulcerative colitis and Crohn's disease affect as many as 700,000 Americans each, according to Takeda.
"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," Takeda VP general medicine Asit Parikh said. "This regulatory submission marks a significant step forward for vedolizumab in the United States, and as a company we are excited about the possibility of providing this community with a new treatment option."