The therapy is approved for both adults and children.
Jazz Pharmaceuticals has launched Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn). The FDA approved Rylaze on June 30, 2021, as a component of a multi-agent chemotherapy regimen for the treatment of acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli-derived asparaginase.
Rylaze was licensed from Ligand Pharmaceuticals.
The only other FDA-approved drug for such patients with allergic reactions has been under global shortage since 2016. Jazz Pharmaceuticals’ Erwinaze (asparaginase erwinia chrysanthemi) has experienced supply and manufacturing issues from the owner and manufacturer of the product, Porton Biopharma Limited. Jazz Pharmaceuticals’ agreement with Porton Biopharma ended in December 2020.
In May 2021, the FDA had authorized Porton Biopharma and its distributor Clinigen to import Erwinase (crisantaspase) into the United States and bring this therapy to physicians.
Jazz licensed Rylaze from Ligand Pharmaceuticals, which received a $2 million payment when the FDA accepted the BLA for review and is entitled to receive a $5 million payment upon the first commercial sale following launch.