Pfizer’s Xeljanz secures marketing authorisation in Europe

3 August 2018 (Last Updated August 3rd, 2018 11:37)

Pfizer has received clearance from the European Commission (EC) to market Xeljanz (tofacitinib citrate) for the treatment of adults suffering from severely active ulcerative colitis (UC).

Pfizer has received approval from the European Commission (EC) to market Xeljanz (tofacitinib citrate) for the treatment of adults suffering from severely active ulcerative colitis (UC).

The indication covers use of 10mg twice-daily (BID) for at least eight weeks, followed by 5mg or 10mg BID of the drug in patients with inadequate response, lost response or intolerance to current standard therapy or a biologic agent.

Xeljanz is an inhibitor of Janus kinase (JAK), and is said to be the first such oral drug approved for this patient population.

The EC clearance is based on findings from three pivotal Phase III studies under the Oral Clinical Trials for Tofacitinib in Ulcerative colitis (OCTAVE) global clinical development programme, and the ongoing OCTAVE Open long-term extension study.

“The EC approval of Xeljanz provides an additional treatment option that can help improve the care of adults in Europe.”

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.”

Previously, the medicine was approved by the EC to treat active psoriatic arthritis (PsA) in patients who have had an inadequate response or intolerance to a previous disease-modifying antirheumatic drug (DMARD) therapy.

Xeljanz is also indicated in combination with methotrexate (MTX), for treating moderate to severe active rheumatoid arthritis (RA) in adults responding inadequately or intolerant to one or more DMARDs.

It additionally gained approval as monotherapy for patients intolerant to MTX or in cases when treatment with MTX is considered inappropriate.

Currently, Xeljanz is available for moderate to severe RA in more than 80 countries, and for moderately to severely active UC in the US, Japan, Peru and Russia.