The Food and Drug Administration doesn't have to follow the recommendation of its panel of outside experts, but with a strong majority saying the drug's efficacy outweighs any potential side effects, I think it's likely the agency approves the drug in August.
The big question at this point is what the label will look like. Pfizer proposed two doses, but given the safety issues, the FDA might only approve the lower dose. That's probably not a major issue; most patients would probably start on the lower dose and only use the higher dose if it was absolutely necessary.
There's also the question of which patients will be tofacitinib will be approved to treat. Many patients fail rheumatoid arthritis drugs, but obviously the earlier a drug can get into the treatment regimen, the more patients there will be available to treat.
Hitting the ground running with the largest potential market is important, because Pfizer isn't the only drugmaker developing an oral rheumatoid arthritis drug. Both Incyte
Getting tofacitinib approved and hitting blockbuster status is important for Pfizer. And not just because it needs to fill the void left by Lipitor. Tofacitinib was discovered at Pfizer, and proving that the big pharma can still develop drugs and not just in-license them should give investor confidence in the future of drugs-only Pfizer a much-needed boost.
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