Pfizer Inc. announced today that an advisory committee of the U.S. Food and Drug Administration has recommended regulatory approval of the company's experimental pill for the treatment of rheumatoid arthritis.
The drug, tofacitinib, was taken from the discovery phase and advanced through clinical trials by scientists at Pfizer's Groton laboratories. Pfizer is hoping that tofacitinib, which if approved is expected to hit $1 billion in sales within a few years, will be the first blockbuster out of its labs since Viagra - discovered by scientists in Sandwich, England - won approval more than a decade ago.
The FDA's Arthritis Advisory Committee voted 8-2 to recommend approval of tofacitinib, one of a new class of drugs called JAK inhibitors. Pfizer said it would be the first rheumatoid arthritis pill to win FDA approval in more than a decade if the agency gives the go-ahead by an expected August deadline.
The recommended approval came after the release of an FDA staff report that cited "serious safety concerns" with patients developing malignancies as patients increased their exposure to the drug.