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# Incyte Complete Response on Once-daily Jakafi
- URL: https://www.fdaweb.com/incyte-complete-response-on-once-daily-jakafi/
- Published: 2023-03-24T12:00:00.000Z
- Updated: 2026-09-14T18:21:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154068

FDA has issued Incyte a complete response letter for Jakafi (ruxolitinib) extended-release tablets, a JAK1/JAK2 inhibitor for once-daily use in treating certain types of myelofibrosis, polycythemia vera and graft-versus-host disease. Jakafi is currently approved in a twice-daily dosage.

“The complete response letter states that the FDA cannot approve the application in its present form,” the company says. “The FDA acknowledged that the study submitted in the New Drug Application (NDA) met its objective of bioequivalence based on area under the curve (AUC) parameters but identified additional requirements for approval. Incyte intends to meet with the FDA to determine appropriate next steps.”