Takeda’s Entyvio (vedolizumab) has become the first biologic therapy to get a provisional yes from the National Institute for Health and Care Excellence as a maintenance therapy for ulcerative colitis.
The cost regulator has issued an appraisal consultation document supporting the drug’s use on the National Health Service, within its marketing authorisation, for adults with moderately to severely active UC if they have not had, or could not tolerate a TNF-alpha inhibitor.
More than 140,000 people in the UK suffer from UC, a chronic and relapsing condition which is characterised by unpredictable symptoms such as urgent diarrhoea, rectal bleeding and extreme fatigue, and thus can significantly affect quality of life.
Enytvio, which became the first biologic to be simultaneously approved for UC and Crohn’s disease by European regulators in May, is a novel alpha-4 beta-7 integrin antagonist which works by blocking a key inflammatory marker on white blood cells. But the drug suppresses immune activity only in gut, as opposed across the whole body, which experts see as “a step change” in the management of the condition.
In clinical trials, more than 40% of people who showed an initial response after six weeks’ of therapy with Entyvio were in remission at the end of year one (compared to 15.9% in the placebo arm), while over half of the patients in the trial (51.6%) showed healing of the gut lining at one year, demonstrating its potential.
A final decision from NICE is expected in April 2015.