Pfizer Inc. (PFE) said its rheumatoid arthritis treatment tofacitinib, one of the company’s leading experimental drugs, was more effective than an older treatment in a large-scale study.
The drug met its primary end-point in the study and no new side effects were found, Pfizer said today in a statement. Pfizer said on a conference call with analysts today that the Food and Drug Administration may need more time than expected to make a decision on approval of the treatment.
The study, dubbed ORAL start, found that tofacitinib was superior to methotrexate in easing pain and swelling of joints caused by rheumatoid arthritis, according to the statement. Results were from the last of three stages of human tests generally required for FDA approval.
Rheumatoid arthritis is a chronic inflammatory disorder that affects about 1.3 million Americans and 23.7 million people worldwide, the company said in the statement.
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