BLAINTRAVENOUSPOWDER, FOR INJECTION SOLUTION, LYOPHILIZED POWDERPriority Review
Approved
Feb 2023
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
5/8 — Partial
Priority Review
LAMZEDE (velmanase alfa-tycv) by Chiesi is alpha-mannosidosis is a lysosomal storage disease that results from reduced activity of the enzyme alpha-mannosidase, caused by gene variants in mannosidase alpha class 2b member 1. Approved for alpha-mannosidosis. First approved in 2023.
Drug data last refreshed 21h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LAMZEDE (velmanase alfa-tycv) is an enzyme replacement therapy for alpha-mannosidosis, a rare lysosomal storage disease caused by deficiency of alpha-mannosidase. The drug provides exogenous alpha-mannosidase that is internalized via mannose-6-phosphate receptor binding and transported into lysosomes to degrade accumulated mannose-rich oligosaccharides. It is administered intravenously as a lyophilized powder for injection solution.
Peak
Early-stage specialty biologic in peak commercial phase with limited direct competition and moderate market penetration potential.
Mechanism of Action
Alpha-mannosidosis is a lysosomal storage disease that results from reduced activity of the enzyme alpha-mannosidase, caused by gene variants in Mannosidase Alpha Class 2B Member 1. Alpha-mannosidase catalyzes the degradation of accumulated mannose-containing oligosaccharides. The deficiency of…
Indications (1)
Clinical Trials (1)
Analysis of Velmanase Alfa (Lamzede®)'s Effects in the Body of Children With Alpha-Mannosidosis Under the Age 3
Started Feb 2025
5 enrolled
Alpha-Mannosidosis
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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.