Submit safety data of Indian patients: CDSCO Panel Tells Sanofi Healthcare on Olipudase Alfa

Written By :  Dr. Divya Colin
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2024-11-10 11:45 GMT   |   Update On 2024-11-10 11:45 GMT
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New Delhi: Responding to the proposal presented by Sanofi Healthcare for updating the prescribing information of Olipudasealfa Powder for concentrate for solution for infusion 20 mg vial, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control (CDSCO) has opined the firm to submit safety data of Indian patients with respect to serious adverse events (SAE’s) and adverse events (AE’s) of all patients treated with the drug Olipudase alfa Powder along with Periodic Safety Update Report (PSUR data).

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The expert panel further added, "The safety and efficacy data are to be deliberated in the presence of an independent expert who is using the drug for the treatment of patients and has not been part of previous studies (PI or Coinvestigator) of the proposed drug in India."

This came after Sanofi Healthcare presented the proposal for the update in Prescribing Information in the posology, use in the special population, overdose and patient counseling information section for Xenpozyme (Olipudase alfa powder for concentrate for solution for infusion 20 mg vial) in line with Company Core Data Sheet (CCDS) version 05 dated 01st Dec 2022 and version 06 dated 04th May 2023.

Olipudase alfa is recombinant human acid sphingomyelinase. 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

At the recent SEC meeting for Endocrinology and Metabolism held on October 15, 2024, the expert panel reviewed the proposal presented by Sanofi Healthcare for the update in the prescribing information in the posology, use in the special populations, overdose and patient counseling information section for Xenpozyme (Olipudase alfa Powder for concentrate for solution for infusion 20 mg vial).
After detailed deliberation, the committee recommended that the firm should submit the safety data of Indian patients with respect to SAEs and AEs of all patients treated with the drug product along with PSUR data.

In addition to the above, the expert panel stated that safety and efficacy data are to be deliberated in the presence of an independent expert who is using the drug for the treatment of patients and has not been part of previous studies (PI or coinvestigator) of the proposed drug in India.

Also Read:Mylan Laboratories Gets CDSCO Nod to Manufacture and Market Epinephrine tartrate Injection

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