Pfizer’s Arthritis Drug Xeljanz (tofacitinib citrate) should not be approved for the treatment of rheumatoid arthritis, CHMP (Committee for Medicinal Products for Human Use) advised the European Medicines Agency on April 25th, 2013.
Pfizer can request a re-examination of the opinion with the next 15 days, EMA (European Medicines Agency) informed.
Xelianz is intended as treatment for moderate to severe active rheumatoid arthritis, a disease of the immune system which damages and inflames the joints. It is designed to be used in patients who did not respond to or could not tolerate at least two other DMARDs (disease-modifying antirheumatic drugs), including biological DMARDs.
Biological DMARDs target specific immune system proteins. They are produced using recombinant DNA technology and are made by cells that have been genetically altered to produce the medicine.
(the studies) were not sufficient to show a consistent reduction in disease activity and structural damage to joints
There were also serious concerns about Xeljanz’ overall safety
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“We have confidence in XELJANZ and believe our application to the EMA demonstrates that XELJANZ has a favorable risk:benefit profile.
XELJANZ’s safety profile is well-characterized, and the issues raised by the EMA, including serious infections, gastrointestinal perforations and malignancies, are familiar to rheumatologists who are experienced working with treatments for patients to manage this difficult disease.
Each regulatory authority will review and interpret applications individually and different assessments are not uncommon.
The re-examination process will enable us to seek to address the CHMP’s questions, and we will continue to work closely with the EMA with the goal of making this medicine available to appropriate patients in Europe.”