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A new rheumatoid arthritis (RA) treatment from Pfizer has been backed for approval by an advisory committee to the US drug regulation agency.
The Food and Drug Administration move follows acceptance of regulatory submission of tofacitinib by the European Medicines Agency and a National Institute for Health and Clinical Excellence rapid review of the Janus Kinase (JAK)-3 inhibitor for treatment of moderate to severe active RA.
The manufacturer hopes that tofacitinib, the first JAK inhibitor, will take the place of Humira as the first-choice treatment for RA.
Approval by the FDA is reportedly anticipated in August.
Tocafitinib could become the first disease-modifying antirheumatic drug (DMARD) taken by mouth to be approved within the last 10 years.
The oral administration of tocafitinib is expected to make the drug, which showed similar efficacy to Humira in a recent Phase III trial, a particularly attractive option to patients and doctors.