The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for Eli Lilly’s leukemia drug, Jaypirca. The recommendation covers the treatment of adults with chronic lymphocytic leukemia (CLL) across all lines of therapy. This decision serves as a final step toward full marketing authorization in the European Union.
The CHMP based its recommendation on positive data from Phase 3 clinical trials. The European Commission expects to deliver a final decision within the next two months. This approval would expand Eli Lilly’s presence in the European hematology market and provide a new treatment option for CLL patients.