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Sanofi Reports Positive Topline Results from Pivotal Phase III JAKARTA Study for JAK2 Inhibitor in Myelofibrosis
Date:5/17/2013

PARIS, May 17, 2013 /PRNewswire/ -- Sanofi (EURONEXT: SAN and NYSE: SNY) announced today that the pivotal study, JAKARTA, examining the selective JAK2 inhibitor SAR302503 for myelofibrosis (MF), met its primary endpoint in both dose groups. The primary endpoint assessed the proportion of patients achieving >/=35% reduction of spleen volume. Consistent with data reported in previous trials, the most common adverse events were anemia, diarrhea, nausea and vomiting. Full results will be presented at an upcoming medical congress.

MF is a rare, debilitating and life-threatening hematologic malignancy characterized by abnormal blood cell production and scarring, or fibrosis, in the bone marrow. 

"Patients with myelofibrosis in advanced stages are desperately ill and in need of treatments that will improve their outcomes. I am pleased with the results of JAKARTA and would like to thank the patients and the investigators in this trial," said Debasish Roychowdhury , M.D., Senior Vice President and Head, Sanofi Oncology. "Since Sanofi's acquisition of the molecule, SAR302503 has moved from Phase I to the completion of pivotal Phase III studies in less than three years, and now we are planning regulatory filings with authorities to make this medicine available for patients."

SAR302503 is a novel, investigational, selective JAK2 inhibitor. Sanofi Oncology is developing SAR302503 for the treatment of the three main types of myeloproliferative neoplasms: primary myelofibrosis, including those previously treated with ruxolitinib; polycythemia vera; and essential thrombocythemia.

About JAKARTA Conducted in 24 countries, the randomized, double-blind, placebo-controlled Phase III JAKARTA'/>"/>

SOURCE Sanofi
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