The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recently gave a positive opinion for tofacitinib, recommending tofacitinib citrate 10 mg and 5 mg twice per day in adult patients with moderate to severe active ulcerative colitis who received an inadequate response, in those no longer responding to treatment or intolerant of conventional or biological agent therapies.

The opinion of the Committee will now reach the European Commission for the final decision and in case of a positive outcome, tofacitinib will be the first and only Janus kinase inhibitor (JAK) indicated – within the European Union – for the treatment of this disease. The drug has recently been approved in the United States, Russia and Japan for moderate to severe active ulcerative colitis.


The studies

The positive opinion took into account data from three studies of the Phase 3 clinical development programme ‘Oral Clinical Trials for tofAcitinib in ulcerative colitis’ (OCTAVE Induction1, OCTAVE Induction 2, and OCTAVE Sustain), and OCTAVE Open, a study that is still ongoing.

Professor Silvio Danese, Head of the Centre for Inflammatory Bowel Diseases of Humanitas and President of the European Crohn’s and Colitis Organization (ECCO), a specialist who has contributed with his studies to the positive opinion of CHMP on tofacitinib, also took part in the process that led to this important result.

Prof. Danese commented: “As a gastroenterologist, I observe the negative consequences every day, both from a physical and mental point of view, on patients affected by this pathology. The efficacy that tofacitinib has shown on the main symptoms of the disease offers doctors an oral therapeutic alternative and an additional option”.


Ulcerative colitis

Ulcerative colitis is a chronic inflammatory bowel disease and generally manifests itself with recurrent episodes of abdominal pain and muco-hematic diarrhea. It is a pathology that has a significant impact on everyday life, affecting work and social relations.

It affects about 2.1 million people in Europe and can affect both sexes, generally between the ages of 15 and 30, with a second peak in incidence between the ages of 50 and 70.