Incyte has received US FDA approval for Jakafi Xr (ruxolitinib) extended-release tablets, a once-daily reformulation of its established JAK1/JAK2 inhibitor, across three hematologic indications: intermediate- or high-risk myelofibrosis, polycythemia vera in patients with inadequate response to or intolerance of hydroxyurea, and steroid-refractory acute or chronic graft-versus-host disease in adults and pediatric patients aged 12 and older.
The approval covers the same indications as the original twice-daily Jakafi (ruxolitinib), first approved in 2011, and does not alter the clinical scope of the franchise. Instead, it introduces a 55 mg extended-release tablet taken once daily, which the company said is bioequivalent to a 25 mg immediate-release tablet taken twice daily based on steady-state drug exposure measures. Jakafi Xr was made available for pharmacy orders by May 8, 2026.
The regulatory basis for approval was a bioequivalence study, presented as a poster at the American Society of Hematology annual meeting in 2025 by Gong et al., demonstrating that the pharmacokinetic profile of the once-daily formulation was comparable to the twice-daily reference product. No new efficacy trials were conducted; the safety profile of Jakafi Xr is established from the existing body of controlled studies across myelofibrosis, polycythemia vera, and both acute and chronic graft-versus-host disease. Common adverse reactions across indications include cytopenias, infections, bruising, dizziness, headache, and diarrhea, consistent with the known profile of the immediate-release formulation.