What Will JAK Inhibitor Safety Jitters Mean For Drug Sales?

FDA Delays Decisions On Pfizer, Lilly/Incyte Drugs

Together with a similar delay for AbbVie’s Rinvoq, the delays appear to stem from a study that raised concerns about the class. But the potential sales impact is less clear.

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The FDA delayed decisions on two JAK inhibitors from Pfizer and one from Lilly, likely because of safety concerns about the class. • Source: Shutterstock

The most likely reason why the US Food and Drug Administration extended its review times for Pfizer Inc.’s abrocitinib and Xeljanz (tofacitinib), as well as Eli Lilly and Company and Incyte Corporation’s Olumiant (baricitinib), is due to safety concerns about JAK inhibitors that arose in January. Less clear is what the delays will mean for the drugs’ commercial prospects.

Lilly/Incyte said 6 April that the FDA had extended the review period for Olumiant in adults with moderate to severe...

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