Drugs giant Pfizer has indicated it has lodged a new drug application for a once-daily modified-release 11 mg tofacitinib citrate tablet. The tablet falls under the trade name Xeljanz. The tablet will now be reviewed by the U.S. Food and Drug Administration (FDA).
The Xeljanz formulation is designed to treat moderate to severe rheumatoid arthritis (an autoimmune disease.) Rheumatoid arthritis is a long lasting disorder that mainly affects joints, rendering them warm, painful and swollen. The most commonly affected area is the wrist and hands. The causes are still uncertain, although a combination of genetic and environmental factors is involved. Symptoms generally appear in people aged between 40 and 50. There is no cure; treatment is based on medication and physiotherapy. In some cases, surgery may help.
The newly developed tablets are intended for patients who do not respond well to the drug methotrexate. Methotrexate is a type of drug known as a disease-modifying anti-rheumatic drug (DMARD). The new drug application sets out to prove that a once-daily tablet is of equivalence to a twice-daily 5 mg tablet.
The tablets have been approved in other regions around the world as a prescription only medicine, but it is not yet available in the U.S. The FDA is due to make a decision by February 2016, after reviewing the clinical evidence.
Rory O’Connor, MD, of Pfizer’s Global Innovative Pharmaceuticals Business, Pfizer, is quoted by Pharmaceutical Technology as saying that if the approval is granted, then it “would bring us one step closer to offering the first and only once-daily oral Janus kinase inhibitor treatment for those living with moderate to severe RA who have had an inadequate response or intolerance to methotrexate.”
