Sanofi prepares for regulatory filing of MF candidate on positive JAKARTA study results
French drug major Sanofi (Euronext: SAN) and NYSE: SNY) this morning (May 17) revealed that the pivotal study, JAKARTA, examining the selective JAK2 inhibitor SAR302503 for myelofibrosis (MF), met its primary endpoint in both dose groups.
The compound was acquired with Sanofi’s acquisition of privately-held USA-based TargeGen for an upfront payment of $75 million, in a deal that could reach $560 in total (The Pharma Letter June 30, 2010).
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.
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