FDA Approves New Dosing Schedule for Jazz Pharmaceuticals’ Rylaze
The FDA has approved Jazz Pharmaceuticals’ supplemental Biologics License Application (sBLA) for an additional dosing schedule for Rylaze (asparaginase erwinia chrysanthemi recombinant) to treat acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) and who have developed hypersensitivity to E. coli-derived asparaginase.
First approved in 2021, Rylaze is part of a multi-agent chemotherapeutic regimen administered on a Monday-Wednesday-Friday dosing regimen, where the patients receive 25 mg/m2 (m2 is a measurement of body surface area) intramuscularly on Monday and Wednesday mornings and 50 mg/m2 intramuscularly on Friday afternoons.
Patients can still receive 25 mg/m2 intramuscularly every 48 hours under the original dosing option.
About Jazz Pharmaceuticals
Jazz Pharmaceuticals plc (a merger of Jazz Pharmaceuticals, Inc. and Azur Pharma plc) is a biopharmaceutical company based in Ireland. It was founded in 2003. One of the company's considerable products is the United States Food and Drug Administration (FDA) approved drug Xyrem (sodium oxybate), the sodium salt of the naturally occurring neurotransmitter γ-Hydroxybutyric acid (GHB). In 2017, net product sales of Xyrem were $1.187 billion, which represented 74% of the company's total net product sales. In 2019, Jazz was granted FDA-approval to market Sunosi with indications for treating excessive daytime sleepiness (EDS) in narcolepsy as well as obstructive sleep apnea (OSA). In 2022, it was announced that Axsome Therapeutics would be acquiring Sunosi from Jazz Pharmaceuticals.
November 24, 2022
