Sanofi reports positive phase 3 myelofibrosis study results
Sanofi has announced that its rare disease treatment to treat myelofibrosis showed positive results in a late-stage phase 3 clinical trial.
The French drugmaker’s pivotal study JAKARTA was evaluating the JAK2 inhibitor SAR302503 for the rare, life-threatening bone marrow disease, myelofibrosis. The trials assessed the proportion of patients achieving >35% reduction of spleen volume. The drug met its primary endpoint in both dose groups.
“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. 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.”
Debasish Roychowdhury, M.D., Senior Vice President and Head, Sanofi Oncology.
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