Novartis’s Jakavi Finds Success in Late-Stage Clinical Trial


A new Novartis (NYSE:NVS) drug, ruxolitinib, which is being marketed as Jakavi, was successful in late-stage trials, Reuters reports. The drug has the potential to become a blockbuster for Novartis, with sales estimated at more than $1 billion annually.

Jakavi is already approved as a treatment in patients with myelofibrosis, a rare form of blood cancer. The recent late-stage trials were testing the drug in patients with polycythemia vera, a disorder of the bone marrow that causes the overproduction of blood cells, particularly red blood cells.

The drug met its primary endpoint in a phase III trial compared with the current best available therapy; Jakavi helped regulated the number of red blood cells in patients with polycythemia vera without the need for phlebotomy (a procedure in which blood is drawn in order to reduce the number of red blood cells.)

“We are encouraged by these pivotal Phase III trial results, which show the potential of ruxolitinib to help patients with polycythemia vera,” said Novartis’ President of Oncology Alessandro Riva, who is also the Global Head of Oncology Development and Medical Affairs for the company, per MarketWatch. ”We plan to submit this data to worldwide regulatory agencies this year as we seek to bring ruxolitinib to patients with polycythemia vera who are no longer responding to are are intolerant of prior therapy.”

Analysts also seem upbeat on the news. David Kaegi, an analyst with J. Safra Sarasin, spoke with Reuters saying that, “With the additional indication of polycythemia vera now likely to get approved next year, Jakavi definitely emerges as another drug new drug with blockbuster potential for Novartis.”

Jakavi is one of Novartis’ “growth products,” having achieved sales of $163 million last year, up from $30 million in 2012. Currently, Novartis markets the drug outside the U.S., and licensed it from Incyte Corp, per Reuters.

The news is particularly exciting for Novartis because ruxolitinib’s success comes in the wake of competitor Sanofi’s failure with a similar drug, fedratinib, which was also being developed for the treatment of myelofibrosis. Sanofi was forced to stop all clinical trials and cancel plans for seeking regulatory approval due to safety concerns regarding the drug.

Polycythemia vera is a rare bone marrow disease, in which your body makes too many red blood cells; the excess blood cells render the blood thicker than normal, causing the blood to clot much more easily. As a result of the increased risk for clots, patients with polycythemia vera can experience heart attacks or strokes. The thicker blood also moves more slowly, meaning organs are likely to be deprived of oxygen. Often, patients suffer from conditions like angina or even heart failure.