Takeda's Entyvio given provisional approval by UK's NICE

26 November 2014

The UK’s National Institute for Health and Care Excellence (NICE) has given a provisional approval to Entyvio (vedolizumab), produced by Japan’s largest drugmaker Takeda Pharmaceutical (TYO: 4502).

Entyvio has become the first biologic treatment to receive a provisional yes for maintenance therapy in ulcerative colitis, with NICE recognizing that vedolizumab’s unique gut-selective mechanism of action represented a step change in the management of ulcerative colitis.

It has been provisionally recommended by NICE within its marketing authorization for adults with moderately to severely active ulcerative colitis if they have not had, or could not tolerate a TNF-alpha inhibitor. The consultation period is now open and the final decision from NICE is expected in April 2015.

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