Pfizer Inc. (PFE)’s experimental pill to treat rheumatoid arthritis, one of the company’s leading drug candidates, raised “serious safety concerns” in trials, U.S. regulators said today.
The pill, tofacitinib, carried increased risks of serious infections and malignancies, in particular a higher chance of lymphoma, Food and Drug Administration staff wrote. The agency released the report ahead of a May 9 meeting of FDA medical advisers who will review tofacitinib’s benefits and risks.
Rheumatoid arthritis is an autoimmune disease in which the body attacks itself. It causes deterioration of the joints, which can make basic tasks such as walking or holding items painful. The condition is treated with anti-inflammatory pills like Aspirin, or drugs that attack the disease directly by modifying the immune system.
The data the FDA saw also didn’t show that the pill stopped the disease from progressing, according to the staff report. “This is particularly important in determining the overall benefit-risk profile of tofacitinib, which is associated with serious safety concerns.”