TSXV:BTI.H - Post by User
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prophetoffactzon Feb 23, 2023 8:03pm
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Post# 35302366
Chiesi
Chiesi As Fabry push with Protalix continues, FDA says yes to Chiesi’s Lamzede ERT for alpha-mannosidosis
Chiesi Farmaceutici SpA scored U.S. FDA clearance of the enzyme replacement therapy (ERT) Lamzede (velmanase alfa-tycv) for non-central nervous system manifestations of alpha-mannosidosis (AM) in adult and pediatric patients. An ultra-rare, progressive lysosomal storage disorder, AM is caused by deficiency in the enzyme alpha-mannosidase. Lamzede is the first ERT to win approval in the indication, characterized by an inability to properly break down certain groups of complex sugars in the body’s cells.