As sales of Incyte Corp.'s approved JAK inhibitor Jakafi (ruxolitinib) begin to pick up steam, a competing myelofibrosis candidate from Sanofi SA moved a step closer to market.

The Paris-based big pharma, which gained rights to JAK drug SAR302503 in its 2010 buyout of TargeGen Inc., reported solid top-line data from the Phase III study dubbed JAKARTA, showing that both dose groups of the drug hit the primary endpoint of reducing spleen volume. The study was conducted under a special protocol assessment with the FDA, and Sanofi anticipates a regulatory filing shortly, though the firm declined to comment on exact timing.

A positive outcome had largely been expected for JAKARTA, which enrolled 289 patients with intermediate-2 or high-risk primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis and measured the proportion of patients who had reductions in spleen volume of 35 percent or