Novartis' Jakavi Meets Primary Goal In Phase III For GVHD
Zacks Investment Research | Oct 17, 2019 12:12AM ET
Novartis AG (NYSE:NVS) announced that the phase III REACH2 study, which evaluated Jakavi (ruxolitinib) for treating patients with steroid-refractory acute graft-versus-host disease (GVHD), has met the primary endpoint.
The study met the primary endpoint of superior overall response rate (ORR) following treatment with Jakavi compared to the best available therapy at day 28.
The positive result from the study will be the basis of regulatory submissions seeking approval of Jakavi for the above-mentioned indication in Europe and other countries. Further analysis of the safety and efficacy data is currently ongoing.
Novartis plans to begin discussions with ex-U.S. regulatory authorities in 2020 regarding the drug’s marketing application.
Jakavi is marketed in the United States as Jakafi by Incyte Corporation (NASDAQ:INCY) .
Meanwhile, a phase III REACH3 study evaluating Jakavi/Jakafi for addressing patients with steroid-refractory chronic GVHD is currently underway. The study is co-sponsored by Incyte and Novartis and data from the same is expected next year.
Shares of Novartis have inched up 1.4% so far this year compared with the Zacks Investment Research
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