Nov 6 The U.S. Food and Drug Administration said
on Tuesday it has approved a new drug to treat rheumatoid
arthritis developed by Pfizer Inc, two weeks ahead of
the date the agency was expected to complete its review.
The drug, Xeljanz, known generically as tofacitinib, is
approved to treat adults with moderate to severe arthritis who
cannot take, or have an inadequate response to, methotrexate, a
standard rheumatoid arthritis treatment.
Rheumatoid arthritis is an autoimmune disease in which the
body's immune system mistakenly attacks healthy tissue, causing
inflammation and pain in the joints. It affects an estimated 1.5
million Americans, the FDA said.
Pfizer's drug works by blocking molecules called Janus
kinases which are implicated in joint inflammation. The drug was
associated with an increased risk of serious infections,
tuberculosis, cancers and lymphoma. It carries a boxed warning,
the most serious available, related to its side effects.