MFDS grants Nexviazyme for Pompe disease

[Newsmp] The Ministry of Food and Drug Safety (MFDS) approved a Pompe disease treatment Nexviazyme (avalglucosidase alfa) from Sanofi-Aventis Korea on Wednesday.

Pompe disease is a disorder caused by a deficiency of the enzyme alpha-glucosidase, which is required for breaking down glycogen in the lysosomes of cells. As glycogen accumulates within the lysosomes, muscle weakness, atrophy, respiratory failure, and cardiomyopathy occur.

Nexviazyme is a genetically modified enzyme medication that serves as a long-term enzyme replacement therapy (ERT) for patients diagnosed with Pompe disease caused by alpha-glucosidase deficiency.

Nexviazyme provides improved dosing and administration compared to Sanofi's Myozyme, recombinant human acid alpha-glucosidase (rhGAA).

The MFDS stated that Nexviazyme modifies the sugar structure of Myozyme, leading to increased cellular absorption and improved efficacy in patients who do not respond to Myozyme.