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