Nexviazyme FDA Approval History
Last updated by Judith Stewart, BPharm on Aug 9, 2021.
FDA Approved: Yes (First approved August 6, 2021)
Brand name: Nexviazyme
Generic name: avalglucosidase alfa-ngpt
Dosage form: Lyophilized Powder for Injection
Company: Sanofi
Treatment for: Pompe Disease
Nexviazyme (avalglucosidase alfa-ngpt) is a hydrolytic lysosomal glycogen-specific enzyme indicated for the treatment of patients with late-onset Pompe disease.
- Pompe disease is caused by a genetic deficiency of alpha-glucosidase (GAA), which results in build-up of glycogen and subsequent irreversible damage to the skeletal muscles and the muscles that support respiratory function.
- Nexviazyme is indicated for the treatment of patients one year of age and older with late-onset Pompe disease [lysosomal acid alpha-glucosidase (GAA) deficiency].
- Nexviazyme works by specifically targeting the mannose-6-phosphate (M6P) receptor, the key pathway for GAA enzyme replacement therapy, to effectively clear glycogen build-up in muscle cells.
- Nexviazyme is administered via intravenous infusion every two weeks.
- The Nexviazyme product label carries a boxed warning for hypersensitivity reactions, infusion-associated reactions, and the risk of acute cardiorespiratory failure in susceptible patients.
- Common adverse reactions include headache, fatigue, diarrhea, nausea, arthralgia, dizziness, myalgia, pruritus, vomiting, dyspnea, erythema, paresthesia and urticaria.
Development timeline for Nexviazyme
Further information
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