Velmanase alfa-tycv

(Lamzede®)

Lamzede®

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Drug updated on 4/17/2024

Dosage FormInjection (intravenous; 10 mg as a lyophilized powder in a single-dose vial)
Drug ClassRecombinant human lysosomal alpha-mannosidases
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of non-central nervous system manifestations of alpha-mannosidosis in adult and pediatric patients.

Summary
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  • Velmanase alfa-tycv (Lamzede) is approved for the management of non-central nervous system manifestations of alpha-mannosidosis in both adult and pediatric patients. It has demonstrated a robust safety profile, with treatment-emergent adverse events not leading to permanent cessation of therapy.
  • Two randomized controlled studies examined the efficacy and safety of velmanase alfa (Lamzede) in treating alpha-mannosidosis, without comparisons to other drugs.
  • These studies documented significant reductions in serum oligosaccharide levels as a primary measure of effectiveness, showing Lamzede's capability in decreasing the accumulation of harmful substances in individuals with alpha-mannosidosis.
  • Evaluations utilizing the 3-minute stair climb test revealed significant and sustained improvements, illustrating not only biochemical control but also enhanced physical capabilities in patients receiving Lamzede.
  • The findings indicate more notable benefits from velmanase alfa treatment in pediatric patients, suggesting that initiating treatment earlier may lead to improved outcomes, particularly in functional measures.
  • Long-term data consolidated in one study provides insights into the durability of effects over time for both adults and pediatric populations; it presents maintenance of improvements up to four years, affirming its long-lasting impact, which is essential for a progressive condition.