Datapoint: Incyte Suffers FDA Snub for Jakafi XR

The FDA last week rejected the extended-release formulation of Incyte’s Jakafi, a JAK inhibitor currently approved to treat myelofibrosis and polycythemia vera, two rare blood cancers, and graft-versus-host disease. The drug is currently approved as a twice-daily tablet — the extended release formulation would cut this down to a once-daily dose. Incyte said it will meet with the FDA “to determine appropriate next steps.” Jakafi was first approved in 2011 for the treatment of myelofibrosis, an indication for which it holds covered or better status for virtually all (99%) insured lives under the pharmacy benefit. About 17% of covered lives have preferred access to Jakafi, growing to 36% with utilization management restrictions applied.

SOURCE: MMIT Analytics, as of 4/3/23

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