Swiss pharmaceutical giant
) recently presented data from two phase III trials (COMFORT-I
and COMFORT-II) on Jakavi (INC424, ruxolitinib) at the 54th
American Society of Hematology (ASH) annual meeting.
Two-year data from the studies showed that Jakavi treatment
resulted in sustained reductions in spleen size in patients
suffering from myelofibrosis, along with improving the quality of
life and lengthening overall survival as compared to placebo or
the best available therapy (BAT).
Results from the two-year follow-up COMFORT-II study showed
that Jakavi helped in sustaining reductions in splenomegaly
(enlarged spleen). The study revealed that 48.3% of patients
treated with the drug achieved a 35% or more decrease in spleen
size. Data from the study also revealed that patients treated
with Jakavi showed an extended overall survival compared to those
in the BAT group. More than 61% patients in the BAT group
switched to Jakavi, but they were considered as BAT patients
during the follow-up analyses.
The other pivotal study, COMFORT-I, also showed a sustained
reduction in spleen volume in Jakavi treated patients. The
COMFORT-I study evaluated the efficacy and safety of the drug.
The study also revealed a continued overall survival benefit in
favor of Jakavi, compared to placebo.
We note that in August this year, the European Commission
approved Novartis' Jakavi for the treatment of myelofibrosis. The
approval was based on encouraging data from the COMFORT
(COntrolled MyeloFibrosis Study with ORal JAK Inhibitor Therapy)
Novartis has licensed Jakavi from
) for its development and commercialization outside the US.
Incyte received approval from the US Food and Drug Administration
(FDA) for Jakafi (US trade name of Jakavi) in November 2011.
Jakavi enjoys orphan drug status for myelofibrosis both in the US
and the EU.
Currently, we have a Neutral recommendation on Novartis.
Novartis carries a Zacks #3 Rank (Hold) in the short run.
However, other pharma companies like
) carry a Zacks #2 Rank (Buy).
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