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
Copyright©2012 PR Newswire.
All rights reserved
Related medicine technology :
1. Sanofi Pasteur Presents Pediatric Data on Investigational Quadrivalent Influenza Vaccine
2. Sanofi US Launches Collaborate Activate Innovation Challenge
3. Sanofi Pasteur to add 2D barcode to six more vaccines
4. Sanofi and Regeneron Announce Publication of Phase 2 Results with LDL Cholesterol-Lowering PCSK9 Antibody in the New England Journal of Medicine
5. Sanofi and Regeneron Announce Patient Enrollment in Cardiovascular Outcomes Trial with Antibody to PCSK9 for Hypercholesterolemia
6. Sanofi and T1D Exchange to Launch Worldwide Study to Investigate Factors for Optimal Care for Young People with Diabetes
7. Sanofi Donates $500,000 to Hurricane Sandy for Immediate and Long-Term Relief Efforts
8. Phase II Trial of Sanofi JAK2 Inhibitor in Myelofibrosis Met Primary Endpoint
9. Sanofi Launches Breakthrough Technology for Cardiovascular and Vascular Surgery Procedures
10. Zacks Bull and Bear of the Day Highlights: Smithfield Foods, Logitech International, Sanofi, Isis Pharmaceuticals and Aegerion Pharmaceuticals
11. Sanofi New Drug Application for Lixisenatide Accepted for Review by FDA