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Sanofi's SAR302503 meets in myelofibrosis

May 18, 2013 12:04 AM UTC

Sanofi (Euronext:SAN; NYSE:SNY) said once-daily 400 and 500 mg doses of oral SAR302503 each met the primary endpoint in the Phase III JAKARTA trial to treat primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF) and post-essential thrombocythemia myelofibrosis (PET-MF). Specifically, both doses improved the proportion of patients with a 35% or greater reduction in spleen volume from baseline to week 24 vs. placebo. The double-blind, international trial enrolled 289 patients with intermediate-2 or high-risk PMF, PPV-MF or PET-MF.

Sanofi said it plans to submit regulatory applications for SAR302503 in the indication, but said it is "premature to comment" on a potential time frame. The pharma, which gained the selective oral Janus kinase-2 (JAK-2) inhibitor through its 2010 acquisition of TargeGen Inc., has an SPA from FDA for the JAKARTA trial. ...