Sanofi Gets CDSCO Panel Nod to Update Prescribing Information for Xenpozyme
New Delhi: The Subject Expert Committee (SEC), functioning under the Central Drugs Standard Control Organisation (CDSCO), has recommended approval for updating the Prescribing Information of Xenpozyme (Olipudase alfa Powder for concentrate for solution for infusion 20 mg vial), manufactured by Sanofi Healthcare India.
This came after the firm presented the proposal of an update in Prescribing Information for Xenpozyme (Olipudasealfa Powder for concentrate for solution for infusion 20 mg vial) in line with Company Core Data Sheet (CCDS) version 04 dated 27th Oct 2022 and version 07 dated 27th June 2024.
Olipudase alfa is a recombinant human acid sphingomyelinase used to treat Acid Sphingomyelinase Deficiency (ASMD) in children and adults.
It is the first and only enzyme replacement therapy in the world for the treatment of Acid Sphingomyelinase Deficiency (ASMD), also known as Niemann–Pick disease. ASMD is a rare lysosomal storage disease caused by mutations in the SMPD1 gene, leading to a deficiency in acid sphingomyelinase and the abnormal accumulation of the primary ASM substrate, sphingomyelin. Olipudase alfa works to hydrolyze sphingomyelin accumulated in body tissues, such as the lungs, liver, spleen, kidneys, and bone marrow.
After detailed deliberation, the committee recommended the proposal of Update of Prescribing Information for Xenpozyme (Olipudasealfa Powder for concentrate for solution for infusion 20 mg vial) in line with Company Core Data Sheet (CCDS) version 04 dated 27th Oct 2022 and version 07 dated 27th June 2024.
