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Novartis' Jakavi Gains EU Approval

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Novartis AG’s (NVS - Free Report) cancer drug Jakavi (INC424/ruxolitinib), a novel JAK1/JAK2 inhibitor, recently received approval from the European Commission for the treatment of myelofibrosis (MF), a life-threatening blood cancer.

The approval was based on encouraging data from the COMFORT (COntrolled MyeloFibrosis Study with ORal JAK Inhibitor Therapy) program, which showed treatment with Jakavi reduced spleen size and manifestations caused by MF. The COMFORT program consisted of two phase III studies – COMFORT I and COMFORT II.

The first pivotal study, COMFORT-I, showed that 41.9% of patients treated with Jakavi achieved at least 35% or 50% reduction in spleen size at 24 weeks in comparison to only 0.7% of patients in the placebo arm.

In the second study, COMFORT-II, treatment with Jakavi resulted in a 35% or more decrease in spleen size in 28% of patients at 48 weeks versus 0% of patients under the best available therapy (BAT) group.

The European approval did not come as a surprise, as Jakavi had earlier received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the treatment of MF.

Novartis has licensed Jakavi from Incyte Corporation (INCY - Free Report) for the development and potential commercialization outside the US. Incyte received approval from the US Food and Drug Administration (FDA) for Jakavi in November 2011.

Jakavi is also being investigated in phase III trials for the treatment of polycythemia vera.   

Our Take

We view Jakavi’s approval for the treatment of myelofibrosis as a major positive for Novartis as this is the first approved medication for MF of the company in the EU.

Currently, we have a Neutral recommendation on Novartis. The company carries a Zacks #3 Rank (Hold rating) in the short run.

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