- The FDA granted approval to Jazz Pharmaceuticals' (NASDAQ:JAZZ) Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) as part of a chemotherapy regimen for acute lymphoblastic leukemia or lymphoblastic lymphoma.
- The approval is for patients one month and older who are hypersensitivity to E. coli-derived asparaginase.
- Rylaze was given Fast Track and orphan drug designations.
- Approval was based on the results of a phase 2/3 single-arm, open-label trial that included 102 patients.
- The company said Rylaze will be available beginning in mid-July.
- The FDA said that there has been a shortage of the only other drug available for this indication since 2016.
- Jazz shares were up 4.1% to $184.97 in after-hours trading.