Pfizer's Arthritis Drug Xeljanz May Not Be Approved To Treat Rheumatoid Arthritis

PfizerCommittee for Medicinal Products for Human Use has advised the European Medicines Agency not to approve the Pfizer's Arthritis Drug Xeljanz for the treatment of rheumatoid arthritis. CHMP advised the Agency on April 25,

EMA informed that a re-examination of the opinion could be requested by Pfizer within the next 15 days. Xeljanz is a drug developed for treating moderate to severe active rheumatoid arthritis.

Rheumatoid arthritis is a disease of immune system, which damages and inflames the joints. Xeljanz is intended to be used in patients who do not respond to or could not tolerate at least two other disease-modifying antirheumatic drugs.

There are specific immune system proteins that are targeted by biological DMARDs. Recombinant DNA technology is used to produce them and they are made by cells that have been genetically altered to produce the medicine.

Effects of Xeljanz were initially tested on animals before studying them in humans. Pfizer provided CHMP with the results of five human studies to suggest the drug's safety and efficacy to treat the disease.

However, CHMP advised that the studies were not convincing enough to show a consistent reduction in disease activity and structural damage to joints, specifically at the lower 5-mg dose of Xeljanz. Neither the studies were sufficient to prove high efficacy of the drug in treating patients who have not responded to at least two other DMARDs treatments.