Pfizer’s New Rheumatoid Arthriitis Pill Held Up by FDA – Potential Bockbuster
Ian Read warned (Pharma news) 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 (Pharma news). The agency has delayed approval until at least November 21 while additional data that was recently submitted by Pfizer (PFE) 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 anti-rheumatic drug, or DMARD, for treating the affliction in more than a decade.
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