Chiesi Global Rare Diseases Receives the US FDA’s Approval of Lamzede (velmanase alfa-tycv) for Alpha-Mannosidosis
Shots:
- The US FDA has approved Lamzede, a recombinant human alpha-mannosidase for adult & pediatric patients with non-central nervous system manifestations of alpha-mannosidosis. The approval was based on multiple trials incl. the P-III & P-II trial evaluating velmanase alfa (1mg/kg, qw, IV) vs PBO
- In the P-III trial, velmanase alfa showed an improvement in the 3-minute stair climbing test, 6MWT & forced vital capacity @12mos. & efficacy was supported by a reduction in serum oligosaccharide concentration. The P-II trial showed the mean absolute & percentage changes from baseline for serum oligosaccharides
- Lamzede received marketing authorization from the EC in 2018 for non-neurological manifestations in patients with mild to mod. AM
Ref: Prnewswire | Image: Chiesi
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