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