laronidase

Orphan Drug Cold Chain RequiredFDA Approved, EMA Approved

Description

Laronidase is a recombinant form of human alpha-L-iduronidase used as enzyme replacement therapy. It is indicated for patients with Hurler and Hurler-Scheie forms of mucopolysaccharidosis I and for patients with Scheie form who have moderate to severe symptoms. While primarily used for MPS I, it has been studied in other lysosomal storage disorders with similar pathophysiology.

Indications & Therapeutic Use

Mucopolysaccharidosis I, lysosomal storage disorders

Global Availability (8 countries)

CountryAccess RouteRegulatory PathwayLead TimeStatus

Available Through

This drug is available for procurement through the following fulfilment partner.

Fulfilment Partner
laronidase
Generic Namelaronidase
Brands1 brand available
Active Ingredientlaronidase
Drug ClassMucopolysaccharidosis I
ManufacturerBioMarin Pharmaceutical Inc.
Dosage FormsIV infusion, 0.58 mg/mL
Medical CodeA16AB05
Orphan StatusYes — Orphan Drug
Cold ChainRequired
Lead Time14 days
Reg. StatusFDA Approved, EMA Approved
Clinical TrialNCT00004454
Countries8 countries
Authority Signals
Last Verified3/21/2026
Data ConfidenceHigh (AI + Pharmacist)
Source Citations9 Validated Nodes