ALDURAZYME
LOE ApproachingBLAVIALPriority Review
Approved
Apr 2003
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
11
Data completeness
6/8 — Strong
Priority Review
ALDURAZYME by BioMarin Pharmaceutical is (gag). Approved for hurler-scheie forms of mucopolysaccharidosis i (mps i), for the treatment of patients with the scheie form of mps i. First approved in 2003.
Drug data last refreshed 37m ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ALDURAZYME (laronidase) is an intravenous enzyme replacement therapy that belongs to the hydrolytic lysosomal glycosaminoglycan-specific enzyme class. It treats mucopolysaccharidosis I (MPS I), a rare genetic lysosomal storage disorder caused by deficiency of the alpha-L-iduronidase enzyme. The drug works by replacing the deficient enzyme to reduce accumulation of glycosaminoglycans in tissues.
$7MPart D
LOE ApproachingMature product on the decline with modest patient volume (153 annual claims); small, stable commercial team expected.
Mechanism of Action
(GAG). Mucopolysaccharidosis I (MPS I) is characterized by the deficiency of α-L-iduronidase, a lysosomal hydrolase which catalyzes the hydrolysis of terminal α-L-iduronic acid residues of dermatan sulfate and heparan sulfate. Reduced or absent α-L-iduronidase activity results in the accumulation…
Indications (2)
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.