Sanofi Gets CDSCO Panel Nod to Update Aldurazyme Prescribing Information
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 (Version dated December 2024) for its enzyme replacement therapy, Aldurazyme (Laronidase for Solution for Injection 2.9 mg/5 mL).
This approval follows Sanofi’s submission seeking alignment of the Indian prescribing information with the US Prescribing Information (USPI) dated December 2023.
Aldurazyme, which contains the active ingredient laronidase, is used for enzyme replacement therapy in patients with Mucopolysaccharidosis I (MPS I), a rare inherited disorder. It is administered intravenously and helps manage non-neurological symptoms such as enlarged liver, joint stiffness, and reduced lung function, which are caused by the accumulation of glycosaminoglycans (GAGs) in body tissues.
Laronidase is taken up by cells through mannose-6-phosphate (M6P) receptors, allowing the enzyme to reach the lysosomes where it breaks down GAGs, thereby reducing the disease burden.
The SEC reviewed the proposal at its Endocrinology and Metabolism meeting held on 22nd April 2025, and recommended approval of the updated prescribing information.
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