Modified-Release RA Drug Under FDA Review

The FDA is reviewing a once-daily formulation of Pfizer’s tofacitinib citrate (Xeljanz) for rheumatoid arthritis (RA).

Xeljanz is indicated to treat adults with moderately to severely active RA who have had an inadequate response or intolerance to methotrexate.

The recommended dose for the Janus kinase (JAK) inhibitor is currently 5 mg administered orally twice a day, though the FDA is now considering an 11-mg, modified-release formulation administered orally once a day.

“If approved, [Xeljanz 11 mg] would bring us one step closer to offering the first and only once-daily oral JAK treatment for those living with moderate-to-severe RA who have had an inadequate response or intolerance to methotrexate,” stated Rory O’Connor, senior vice president and head of global medical affairs for Pfizer’s Global Innovative Pharmaceuticals Business.

The FDA is anticipated to act on the New Drug Application (NDA) for Xeljanz 11 mg in February 2016.

The NDA is based on clinical data that demonstrated the drug’s equivalence in key pharmacokinetic parameters to the recommended 5-mg, twice-daily formulation.

Xeljanz has a boxed warning for malignancies and serious infections, including tuberculosis. Use of the drug can also increase the risk of shingles and certain cancers.

Common side effects include upper respiratory tract infections, headache, diarrhea, and nasal congestion.