FDA Approves First Once-Daily Oral JAK Inhibitor for RA

Tofacitinib citrate (Xeljanz) is an extended-release tablet for patients with moderate-to-severe rheumatoid arthritis.

The FDA today approved Pfizer’s tofacitinib citrate (Xeljanz), an extended-release tablet treatment for patients with moderate-to-severe rheumatoid arthritis (RA). The drug is the first and only once-daily oral Janus kinanse inhibitor for the treatment of RA.

The 11 mg tablets are taken once-daily for RA patients who have had an intolerance to methotrexate or an inadequate response.

“Pfizer continues to be an innovator in inflammation and immunology,” said Category Development Lead at Pfizer, Michael Corbo. “The introduction of the first and only once-daily oral JAK inhibitor for RA, Xeljanz XR, builds upon Pfizer’s tradition of developing patient-centered therapies.

Both Xeljanz and Xeljanz XR can be taken with or without methotrexate or other nonbiologic disease-modifying antirheumatic drugs.

It is not yet known if the medications are safe for children or patients with hepatitis B or C. Subsequently, patients with severe liver problems should not take Xeljanz or Xeljanz XR.

Additionally, these treatments may lower the body’s ability to fight infections, and may carry a higher risk for developing shingles. Patients should also be tested for tuberculosis before starting the treatment.

Adverse effects may include upper respiratory tract infections, headache, diarrhea, nasal congestion, sore throat, and runny nose.

“The availability of Xeljanz XR provides physicians with a new treatment option for people with RA who may prefer an oral once-daily treatment,” added Clinical Professor at the University of Texas Southwestern Medical Center, Roy Fleischmann.