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최종편집 2024-05-23 08:27 (목)
MFDS grants Nexviazyme for Pompe disease
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MFDS grants Nexviazyme for Pompe disease
  • Hyeokgi Lee, Newsmp
  • 승인 2023.03.30 23:55
  • 댓글 0
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[Newsmp] The Ministry of Food and Drug Safety (MFDS) approved a Pompe disease treatment Nexviazyme (avalglucosidase alfa) from Sanofi-Aventis Korea on Wednesday.

▲ Nexviazyme
▲ Nexviazyme

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.


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