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Takeda to present phase III data for Crohn’s and colitis treatment
Takeda has confirmed it will present data relating to the performance of its Entyvio treatment for ulcerative colitis and Crohn's disease during the 21st United European Gastroenterology Week in Vienna, which gets underway on October 18th.
However, the abstracts for these presentations have been released ahead of the event and show that the efficacy noted in the first 52 weeks of the phase III Gemini trial was maintained over the course of a further year of open-label follow up.
The initial double-blind, randomised, placebo-controlled Gemini 1 and 2 trials were extended to assess long-term safety, with all patients who completed or withdrew from the initial phase eligible to enrol.
Patients considered to be in the efficacy population – those that saw the initial trials through to conclusion – received 300 mg IV doses of Entyvio every four weeks. Of those, 66 per cent were found to be in clinical remission at week 52, with this figure rising to 73 per cent by week 104.
Also known by its scientific name vedolizumab, Entyvio has recently been approved by the US Food and Drug Administration and the European Union.
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