LAMZEDE (velmanase alfa-tycv)
LAMZEDE is indicated for the treatment of Alpha-Mannosidosis.
How LAMZEDE Works
Alpha-mannosidosis is caused by a deficiency in the alpha-mannosidase enzyme, which leads to the accumulation of mannose-rich oligosaccharides within lysosomes. Velmanase alfa-tycv provides an exogenous source of this enzyme to replace the missing or reduced natural activity. The drug binds to mannose-6-phosphate receptors on the cell surface, allowing it to be internalized and transported into the lysosomes. Once inside, the enzyme catalyzes the degradation of accumulated oligosaccharides to reduce cellular buildup.
Details
- Status
- Prescription
- First Approved
- 2023-02-16
- Patent Cliff
- 2030
- Routes
- N/A
- Dosage Forms
- POWDER, FOR INJECTION SOLUTION, LYOPHILIZED POWDER
LAMZEDE Approval History
What LAMZEDE Treats
1 indicationsLAMZEDE is approved for 1 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Alpha-Mannosidosis
LAMZEDE Boxed Warning
SEVERE HYPERSENSITIVITY REACTIONS Hypersensitivity Reactions Including Anaphylaxis Patients treated with LAMZEDE have experienced hypersensitivity reactions, including anaphylaxis. Appropriate medical support measures, including cardiopulmonary resuscitation equipment , should be readily available during LAMZEDE administration. If a severe hypersensitivity reaction (e.g., anaphylaxis) occurs, discontinue LAMZEDE immediately and initiate appropriate medical treatment. In patients with severe hype...
WARNING: SEVERE HYPERSENSITIVITY REACTIONS Hypersensitivity Reactions Including Anaphylaxis Patients treated with LAMZEDE have experienced hypersensitivity reactions, including anaphylaxis. Appropriate medical support measures, including cardiopulmonary resuscitation equipment , should be readily available during LAMZEDE administration. If a severe hypersensitivity reaction (e.g., anaphylaxis) occurs, discontinue LAMZEDE immediately and initiate appropriate medical treatment. In patients with severe hypersensitivity reaction, a desensitization procedure to LAMZEDE may be considered [see Warnings and Precautions ( 5.1 )]. WARNING: SEVERE HYPERSENSITIVITY REACTIONS See full prescribing information for complete boxed warning. Hypersensitivity Reactions Including Anaphylaxis Appropriate medical support measures, including cardiopulmonary resuscitation equipment , should be readily available. If a severe hypersensitivity reaction occurs, discontinue LAMZEDE immediately and initiate appropriate medical treatment. ( 5.1 )
LAMZEDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
LAMZEDE FDA Label Details
Indications & Usage
FDA Label (PDF)LAMZEDE is indicated for the treatment of Alpha-Mannosidosis.
WARNING: SEVERE HYPERSENSITIVITY REACTIONS Hypersensitivity Reactions Including Anaphylaxis Patients treated with LAMZEDE have experienced hypersensitivity reactions, including anaphylaxis. Appropriate medical support measures, including cardiopulmonary resuscitation equipment , should be readily av...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.