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Novartis' Jakavi Meets Primary Goal in Phase III for GVHD

Zacks Equity Research

Novartis AG 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 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 industry’s increase of 0.2%.

Notably in May 2019, the FDA approved Jakafi for the treatment of steroid-refractory acute GVHD in adult and pediatric patients aged 12 years or older.

The approval was based on encouraging data from REACH1, an open-label, single-arm, multicenter study of Jakafi in combination with corticosteroids in patients with steroid-refractory grade II-IV acute GVHD.

Jakafi, a first-in-class JAK1/JAK2 inhibitor, is approved in the United States for the treatment of patients with polycythemia vera (PV), who had an inadequate response to or are intolerant to hydroxyurea. The drug also won the nod for treating patients with intermediate or high-risk myelofibrosis (MF) including primary MF, post-PV MF and post-essential thrombocythemia MF.

Zacks Rank & Stocks to Consider

Novartis currently has a Zacks Rank #3 (Hold). Better-ranked stocks in the large-cap pharma sector include GlaxoSmithKline plc GSK and AbbVie Inc. ABBV, both carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

GlaxoSmithKline’s earnings estimates have been revised 2.1% upward for 2019 and 0.3% for 2020 over the past 60 days. The stock has rallied 10.6% year to date.

AbbVie’s earnings estimates have moved 0.7% north for 2019 and 0.8% for 2020 over the past 60 days.

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