) 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
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)
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
) 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.
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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