Generics
Takeda submits New Drug Application in Japan for ulcerative colitis treatment
24 August 2017 -

Japanese pharmaceutical firm Takeda Pharmaceutical Co Ltd (TSE: 4502) has submitted a New Drug Application (NDA) to the Ministry of Health, Labour and Welfare in Japan, the company announced on Thursday.

The NDA was submitted for the company's investigational humanised monoclonal antibody vedolizumab (generic name and development code: MLN0002) which is intended to be used in the treatment of adults with moderately to severely active ulcerative colitis (UC).

The filing follows data acquired from the Study CCT-101 trial, a multicentre, randomised, double-blind, placebo-controlled, parallel-group Phase 3 study that examined the efficacy, safety and pharmacokinetics of vedolizumab induction and maintenance treatment.

A total of 292 Japanese patients with moderate or severe UC took part in the trial. Further data from Study CCT-101 is expected to be presented at a scientific meeting in the future.

"UC is a chronic, progressive inflammatory disease of the large intestine, which typically affects young adults," said Toshiro Heya, head of Takeda Development Centre Japan. "The disease has a high impact on their quality of life with symptoms including diarrhoea, rectal bleeding, incontinence and abdominal pain.

"Through this submission, we may provide an alternative treatment option to the increasing number of people with UC in Japan."

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