Source: Dow Jones
WASHINGTON -- The US Food and Drug Administration (FDA) questioned the safety and effectiveness of a proposed Pfizer drug for rheumatoid arthritis.
The drug, tofacitinib, is designed to treat the disease in a different manner than currently-approved therapies. The product was set to be reviewed by the FDA's arthritis drugs advisory committee Wednesday.
The FDA said Monday that tofacitinib might be associated with an increased risk of cancer such as lymphoma and that it increased the risk of serious infections, some of which were fatal. The agency also said it could not make "definitive conclusions" regarding the drug's effectiveness on a measure that looked at disease progression.
The FDA released a review of the product in preparation for Wednesday's meeting. Tofacitinib works to inhibit a cell-signaling mechanism referred to as JAK and is a key drug in Pfizer's pipeline.
The company studied the drug in about 4,800 patients. Five studies were submitted to the FDA in support of the drug's approval. Most of the patients in the studies had not responded to initial therapy with a drug called methotrexate.
One study focused on patients who had an inadequate response to newer drugs called TNF inhibitors such as Remicade or Humira, which work to block a substance in the body called tumor necrosis factor (TNF), which can cause inflammation and lead to immune-system diseases, such as rheumatoid arthritis, Crohn's disease and ulcerative colitis.
Pfizer has said it believes the side-effect profile of tofacitinib is similar to other treatments on the market. The labels for TNF-blockers warn of serious and sometimes fatal infections and a possible increased risk of getting certain types of cancer.
The FDA's panel, which is made up of non-FDA medical experts, will be asked to vote on whether it thinks the drug should be approved. The FDA is not required to follow the advice of its panels, but usually does.
Rheumatoid arthritis is a chronic inflammatory disorder that usually affects small joints in the hands and feet.
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