Ian Read warned this would happen. The FDA has delayed approval of tofacitinib, a rheumatoid arthritis pill that some Wall Streeters have been betting will become a blockbuster seller. The agency has delayed approval until at least November 21 while additional data that was recently submitted by Pfizer is reviewed. Although the drugmaker was not asked to provide additional studies, the review constitutes a "major amendment" to the approval application.
The drug would be the first in a class of medications known as JAK inhibitors and data has indicated the pill would offer similar efficacy to such widely used injectables that, collectively, generate some $13 billion in annual sales for treating rheumatoid arthritis. Tofacitinib would also be the first new oral disease-modifying antirheumatic drug, or DMARD, for treating the affliction in more than a decade.
This past May, an FDA advisory committee voted 8-2 to recommend agency approval, but late last month, Pfizer ceo Ian Read told analysts that a delay in approval was likely. He also disclosed that tofacitinib met its primary goals in a late-stage clinical trial that compared the pill with methotrexate, but noted this study was not part of the approval application.