CDSCO Panel Clears Sanofi's Updated Myozyme Insert, Seeks Revision on Administration Guidance

However, the approval is subject to the inclusion of a critical safety instruction. The SEC has mandated that the following statement be added under Section 4.2 – Posology and Method of Administration:

“In case of any infusion-related reaction, if required, the patient should be transferred to a nearby hospital/clinical facility for treatment.”

In addition to this condition, the committee has directed the company to submit the revised Package Insert to CDSCO for further evaluation.

This recommendation follows Sanofi’s proposal for the approval of the Updated Package Insert (dated October 2024) for Myozyme 50 mg, which includes revisions in the following sections: Posology and Method of Administration, Special Warnings and Precautions for Use, Drug Interactions, Undesirable Effects, Overdose, Pharmacological Properties, Other administrative updates

These revisions are based on the updated European Summary of Product Characteristics (EU SmPC) dated 14 March 2024.

Alglucosidase alfa is a recombinant form of human acid alpha-glucosidase (rhGAA) produced in Chinese Hamster Ovary (CHO) cells. It is classified as a Hydrolytic Lysosomal Glycogen-specific Enzyme and is indicated for enzyme replacement therapy (ERT) in patients with Pompe disease (glycogen storage disease type II), including infantile-onset Pompe disease.

The recommendation was made during the SEC meeting on Endocrinology and Metabolism held on 14th May 2025, where the expert panel deliberated on Sanofi’s submission and aligned the changes with the latest regulatory standards adopted in the EU.

The firm is now required to revise and resubmit the updated insert to CDSCO in accordance with the committee’s direction.

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