Sanofi Gets CDSCO Panel Nod to Update Aldurazyme Prescribing Information

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2025-05-24 13:25 GMT | Update On 2025-05-24 13:25 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 (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.

Also Read: Drug alert: CDSCO flags 60 formulations as not of standard quality

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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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Sanofi Gets CDSCO Panel Nod to Update Aldurazyme Prescribing Information

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