Swiss pharmaceutical giant Novartis (NVS) 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) program.
Novartis has licensed Jakavi from Incyte Corporation (INCY) 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 Sanofi (SNY), Roche (RHHBY) and Bayer (BAYRY) carry a Zacks #2 Rank (Buy).
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