Pfizer has secured approval from the European Commission (EC) for its Xeljanz (tofacitinib citrate) for the treatment of moderately to severely active ulcerative colitis (UC).
The marketing authorization has been granted for Xeljanz10 mg twice-daily (BID) for at least eight weeks, followed by Xeljanz 5mg BID or 10 mg BID, to treat adult patients with moderately to severely active UC who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.
UC is a chronic and debilitating inflammatory bowel disease, which affects around 2.1 million people in Europe. Its symptoms include chronic diarrhea with blood and mucus, abdominal pain and cramping, and weight loss.
Xeljanz is claimed to be the first and only oral therapy and Janus kinase (JAK) inhibitor secured approval for this patient population.
The approval is based on data from three pivotal phase 3 studies from the oral clinical trials for tofacitinib in ulcerative colitis global clinical development program.
Pfizer inflammation and immunology regional president Angela Lukin said: “Ulcerative colitis is a chronic disease that can develop at any age, be difficult to manage and affect multiple aspects of daily life.
“The EC approval of XELJANZ provides an additional treatment option that can help improve the care of adults in Europe living with this debilitating inflammatory bowel disease.”
Last year, Xeljanz, in combination with methotrexate (MTX), secured approval from the EC to treat moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs (DMARDs), and as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate.
In June this year, Xeljanz, in combination with MTX, received EC approval to treat psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy.
Xeljanz is currently approved in more than 80 countries to treat adult patients with moderate to severe rheumatoid arthritis.
In addition, Xeljanz is an approved treatment for active psoriatic arthritis.