Incyte wins FDA approval for extended-release Jakafi XR
Updated
Updated · MarketWatch · May 1
Incyte wins FDA approval for extended-release Jakafi XR
11 articles · Updated · MarketWatch · May 1
The once-daily ruxolitinib tablet is cleared for adults with intermediate- or high-risk myelofibrosis, polycythemia, and for adults or children with graft-versus-host disease after prior systemic therapy.
Approval was based on a study showing a 55mg Jakafi XR tablet taken once daily is bioequivalent to a 25mg immediate-release Jakafi tablet taken twice daily.
Chief executive Bill Meury said the new formulation expands treatment choice while preserving Jakafi's established role in haematology, including myeloproliferative neoplasms and GVHD.
Could Jakafi XR’s once-daily dosing truly improve patient outcomes, or are there hidden challenges with adherence and side effects yet to be addressed?
With competitors racing to develop next-generation MPN drugs, can Jakafi XR maintain Incyte’s market dominance or is a shakeup inevitable?