Pfizer Inc.'s Xeljanz drug for treating moderate to severe active rheumatoid arthritis (RA) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency.
The European Commission (EC) will now make a final decision on whether to use the drug, taking into account the CHMP’s positive recommendation. The drug, if the EC approves it, will then be used in combination with methotrexate to treat RA patients who have not responded well to, or are intolerant to, one or more disease-modifying antirheumatic drugs.
“More than 2.9 million people are currently living with moderate to severe rheumatoid arthritis in Europe. Even with multiple therapeutic options, many of these people may not adequately respond to currently available treatments, including methotrexate,” Chief Development Officer Michael Corbo said in a statement. “The positive CHMP opinion for tofacitinib is an important milestone as we work to bring this new oral treatment option to people in the European Union living with moderate to severe active rheumatoid arthritis.”