Takeda’s Experimental Bowel Drug Effective, Studies Find

Takeda Pharmaceutical Co.’s experimental drug effectively treats ulcerative colitis and Crohn’s disease, inflammatory bowel diseases that affect as many as 1.4 million Americans, two studies found.

Among patients with ulcerative colitis who took Takeda’s intravenous drip vedolizumab for a year, at least 40 percent had a temporary end to symptoms, compared with those who took placebo for the same period, according to results published today in the New England Journal of Medicine. A separate study found the drug helped Crohn’s patients reach remission after a year of treatment, compared with those on placebo.

If approved, vedolizumab would offer a new option for patients as about 10 percent each year are estimated to lose response to each of the latest class of treatments available such as Johnson & Johnson’s Remicade, AbbVie Inc.’s Humira and UCB SA’s Cimzia, said Miles Sparrow, a gastroenterologist at the Alfred Hospital in Melbourne, Australia.

“These are diseases of life time, a significant percentage of patients would have lost response,” Sparrow said in a telephone interview before the announcement. “When these diseases are not treated or undertreated, the burden of the disease is very significant for patients. They really feel miserable versus when they are well their quality of life will be normal or nearly normal.”

The results are a part of data Takeda filed to seek approvals for the drug in the U.S. and Europe in June and March, respectively. Asia’s largest drugmaker is looking for a new revenue source to replace its best-selling Actos diabetes treatment which faces competition from cheaper copycat drugs.

Study Results

One study involved 895 patients, ages 18 to 80 who were diagnosed with moderate to severe active ulcerative colitis and had failed with at least one conventional therapy. It was the last stage of patient studies generally required for regulatory review.

Vedolizumab, or placebo, were given at the start, second and sixth weeks of the trial initially. Patients who took the medicine received the drip every four or eight weeks as maintenance, while those who had placebo received it every four weeks.

As many as 1.4 million Americans are estimated to suffer from inflammatory bowel disease at a cost of $1.7 billion for care, according to the Centers for Disease Control and Prevention.

Over the long term, as much as 75 percent of patients with Crohn’s disease and 25 percent those with ulcerative colitis will require surgery, CDC said.

Patients who took vedolizumab were more likely to have a remission after a year of treatment compared with the group who took placebo, the study said. Side effects were more common with the people who took the medicine, it said.

Takeda fell 1.7 percent to 4,470 yen in Tokyo trading yesterday. The stock has risen 16 percent this year.

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