23 March 2023 - Incyte today announced that the US FDA has issued a complete response letter for ruxolitinib extended release tablets, a JAK1/JAK2 inhibitor, for once daily use in the treatment of certain types of myelofibrosis, polycythemia vera and graft versus host disease.

The FDA acknowledged that the study submitted in the new drug application met its objective of bioequivalence based on area under the curve parameters but identified additional requirements for approval.

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