Product/Composition:- | Alglucosidase Alfa IV |
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Strength:- | 50 mg/vial |
Form:- | Lyophilized powder |
Reference Brands:- | Lumizyme®(US & EU) |
MOQ | As per the manufacturer batch size |
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Alglucosidase alfa is an enzyme replacement therapy that supplies the deficient acid α-glucosidase enzyme in Pompe disease. It breaks down glycogen in muscles, reducing accumulation. Benefits include improved muscle strength, respiratory function, and mobility, leading to better quality of life and slowed disease progression in Pompe patients.
Alglucosidase alfa, marketed as Lumizyme® and Myozyme®, is approved in the US and EU for Pompe disease. Regulatory dossiers include extensive clinical trial data, manufacturing standards, and safety profiles submitted to the FDA and EMA, supporting approval for intravenous use. Dossiers demonstrate its efficacy in improving muscle strength, breathing, and mobility. Dosing is individualized based on patient weight and disease severity. For detailed insights on regulatory processes, dossier submissions, and market approvals in the EU and US, visit PharmaTradz, your trusted source for pharmaceutical regulatory insights and industry updates.