FDA accepts application for Pfizer arthritis drug
Tuesday, December 20, 2011
NEW YORK (AP) — Drugmaker Pfizer Inc. says the Food and Drug Administration has accepted its application for approval of its experimental drug for adults with moderate to severe rheumatoid arthritis.
The FDA says it expects to rule by August 2012 on the application for tofacitinib (toh-FAH'-sit-eh-nib), which Pfizer has touted as a promising new treatment for the autoimmune disease.
Pfizer says it's also applied for approval by regulators in Japan, and the European Medicines Agency is reviewing the drug.
Tofacitinib is in a hot new class of pills for rheumatoid arthritis called JAK inhibitors, which block the janus kinase enzyme. The enzyme plays a key role in the inflammation process in which the immune system attacks joints, particularly in the hands and feet.
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