CDSCO Panel Approves Fabrazyme Label Update, Asks Sanofi to Submit EMA Nod

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2025-05-25 09:30 GMT | Update On 2025-05-25 09:30 GMT

New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has granted approval to Sanofi Healthcare India Pvt. Ltd. to update the prescribing information for Fabrazyme (Agalsidase Beta Powder for Concentrate for Solution for Infusion, 35 mg and 5 mg) in line with the company's global core safety data.

The updated prescribing information, dated October 2024, is aligned with the firm’s Company Core Data Sheet (CCDS) versions 5 (dated 06 May 2021), 6 (dated 18 November 2021), and 7 (dated 20 July 2023).

Fabrazyme contains agalsidase beta, a recombinant form of the human enzyme alpha-galactosidase A, used for the treatment of Fabry disease—a rare genetic disorder caused by the accumulation of globotriaosylceramide (GL-3) in various body tissues. Administered via intravenous infusion, the enzyme helps break down GL-3 and reduce the disease’s impact on organs such as the kidneys and heart.

The SEC made the recommendation during its Endocrinology and Metabolism meeting held on 22 April 2025.

In addition to approving the update, the committee directed the company to submit the European Medicines Agency (EMA) approval of the revised prescribing information to CDSCO for further evaluation.

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Dr. Divya Colin

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

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CDSCO Panel Approves Fabrazyme Label Update, Asks Sanofi to Submit EMA Nod

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