Jazz announces the EMA’s CHMP adopted a positive opinion for JZP458

Jazz Pharmaceuticals announced that the European Medicines Agency’s, EMA, Committee for Medicinal Products for Human Use, CHMP, adopted a positive opinion recommending the marketing authorization of JZP458 for use as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia, ALL, and lymphoblastic lymphoma, LBL, in adult and pediatric patients who developed hypersensitivity or silent inactivation to E. coli-derived asparaginase. “Today’s positive CHMP opinion is welcome news for those in the ALL and LBL community who are unable to be treated with E. coli-derived asparaginase due to hypersensitivity reactions,” says Robert Iannone, MD., M.S.C.E., executive vice president, global head of research and development of Jazz Pharmaceuticals. “We look forward to receiving the final decision that will help bring us one step closer to delivering a reliable supply of recombinant Erwinia asparaginase to patients in the European Union.”