WILMINGTON, DE — Incyte (Nasdaq: INCY) recently received U.S. Food and Drug Administration approval for Jakafi XR, a once-daily extended-release version of ruxolitinib, giving patients with several chronic blood disorders an alternative to the twice-daily regimen that has defined one of the company’s core oncology products for more than a decade.
The approval covers adults with intermediate- or high-risk myelofibrosis and polycythemia vera that is resistant or intolerant to hydroxyurea, along with adults and children age 12 and older with steroid-refractory acute or chronic graft-versus-host disease following prior systemic treatment failure.
The FDA based its decision on clinical data showing the extended-release formulation achieved bioequivalent drug exposure compared with twice-daily immediate-release Jakafi, supporting comparable day-long therapeutic exposure with a single daily tablet.
The approval gives Incyte a lifecycle extension opportunity for Jakafi, which has remained a key revenue driver for the biotechnology company since its initial approval in 2011, while potentially improving treatment adherence for patients managing chronic hematologic cancers and transplant-related complications.
“Patients living with chronic conditions like MPNs and GVHD often struggle with managing complex treatment regimens or have multiple conditions,” Naveen Pemmaraju, professor of leukemia at the University of Texas MD Anderson Cancer Center, said in a statement.
Simplified dosing regimens have become an increasing focus across the pharmaceutical industry as drugmakers seek to improve patient adherence, extend product competitiveness, and differentiate therapies in crowded specialty-treatment markets.
Jakafi XR became available for pharmacy orders May 8, according to Incyte.
The safety profile for the extended-release formulation was consistent with prior studies of immediate-release Jakafi.
Common adverse reactions included low platelet and red blood cell counts, infections, bruising, dizziness, diarrhea, hypertension, anemia, and swelling depending on the patient population studied.
Myelofibrosis and polycythemia vera are rare chronic blood cancers that disrupt normal blood cell production and can increase risks including severe anemia, blood clots, stroke, heart attack, and organ enlargement.
Graft-versus-host disease is a potentially serious immune complication that can develop after donor stem cell transplantation when transplanted immune cells attack healthy tissue.
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