Incyte's Jakafi 1st drug OK'd in polycythemia vera
This article was originally published in Scrip
One day ahead of its Prescription Drug User Fee Act action date, Incyte's oral JAK1/JAK2 inhibitor Jakafi (ruxolitinib) won the FDA's approval in patients with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea – the first drug to gain that indication in the US.
You may also be interested in...
The latest drug development news and highlights from our US FDA Performance Tracker.
Emerging Company Profile: Coming off its first partnership and a $43.2m IPO, Syros looks ahead to data later this year for its first two clinical candidates, both first-in-class agents that regulate gene expression.
The JAK1/2 inhibitor may add an indication for acute graft-versus-host disease, though based on a single, open-label Phase II trial that showed a 55% response rate in a high-mortality indication.