FDA postpones decision on Pfizer RA drug, citing time needed to review new data
NEW YORK — The Food and Drug Administration has postponed its decision whether or not to approve an experimental arthritis drug made by Pfizer, the drug maker said.
Pfizer said the FDA had extended its action date for the drug tofacitinib by three months, to Nov. 21, because additional analyses of data that the company submitted constituted a "major amendment" to Pfizer's regulatory application and will require additional time to review.
If approved, the drug, designed to treat moderately to severely active rheumatoid arthritis, will be the first of a new class known as Janus kinase, or JAK inhibitors. Tofacitinib would also be the first new oral disease-modifying antirheumatic drug for RA in more than 10 years, the company said.