28 March 2023 - - The US Food and Drug Administration 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, US-based Incyte (NASDAQ: INCY) said.

The complete response letter states that the FDA cannot approve the application in its present form. 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.

Incyte intends to meet with the FDA to determine appropriate next steps.

The NDA was based on two studies designed to show that ruxolitinib XR tablets are dosage strength proportional and bioequivalent to Jakafi (ruxolitinib) tablets.

The first study was designed to determine the relative bioavailability of ruxolitinib XR tablets to Jakafi tablets and to demonstrate that ruxolitinib XR tablets are dosage strength proportional to Jakafi tablets.

The second study was an open-label, randomized, two-period, two-way crossover study in 63 healthy adults evaluating the bioequivalence of the highest strength of ruxolitinib XR tablets (50 mg) dosed once-daily to the highest strength of Jakafi tablets (25 mg) dosed twice-daily, following a single dose and at steady-state.

Study results demonstrated that ruxolitinib XR 50 mg tablets dosed QD is bioequivalent to Jakafi 25 mg tablets dosed BID, based on AUC parameters.

Jakafi (ruxolitinib) is a JAK1/JAK2 inhibitor approved by the US FDA for treatment of polycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea; intermediate or high-risk myelofibrosis, including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults; steroid-refractory acute GVHD in adult and pediatric patients 12 years and older; and chronic GVHD after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.

Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics.