Takeda’s Bowel Disease Drug Approved by U.S. RegulatorsDrew Armstrong and Anna Edney
Takeda Pharmaceutical Co. won approval from U.S. regulators for a treatment against the two most common inflammatory bowel diseases.
The drug, Entyvio, also known as vedolizumab, was cleared for adults with moderate to severe ulcerative colitis and moderate to severe Crohn’s disease, the Food and Drug Administration said today in a statement.
“Ulcerative colitis and Crohn’s disease are debilitating diseases that impact the quality of life of those who have these conditions,” said Amy Egan, acting deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research. “Although there is no cure for these conditions, today’s approval provides an important new treatment option for patients who have had an inadequate response to conventional therapy.”
Entyvio works in a similar way to Biogen Idec Inc.’s Tysabri, a multiple sclerosis drug that carries a boxed warning about the risk of a rare, deadly brain infection, known as progressive multifocal leukoencephalopathy. None of the more than 3,000 patients studied in Takeda clinical trials had the infection, the FDA said in its statement.
Entyvio is projected to generate sales of 37.5 billion Japanese yen ($370 million) by 2018 for Osaka, Japan-based Takeda, according to analysts surveyed by Bloomberg.
About 620,000 Americans suffer from ulcerative colitis, which inflames the linings of the large intestine and can cause ulcers. Crohn’s disease can cause inflammation anywhere in the gastrointestinal tract, though the condition usually occurs in the small bowel known as the ileum. More than 500,000 people have been diagnosed with the disease in the U.S., the FDA said. Both can cause discomfort, pain and diarrhea.