Basic Information
Nexviadyme
Regulatory Information
EMEA/H/C/005501
June 24, 2022
November 11, 2021
5
August 8, 2024
Company Information
Netherlands
Paasheuvelweg 25 1105 BP Amsterdam
Sanofi B.V.
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Nexviadyme (avalglucosidase alfa) is indicated for long-term enzyme replacement therapy for the treatment of patients with Pompe disease (acid ?-glucosidase deficiency).
Overview Summary
Nexviadyme is an enzyme replacement therapy used to treat patients with Pompe disease, a rare inherited disorder caused by the lack of an enzyme called alpha-glucosidase. Patients with Pompe disease have a build-up of glycogen (complex sugars) in body tissues, including the heart, lung and skeletal muscles, causing enlarged heart, breathing difficulties and muscle weakness. Nexviadyme contains the active substance avalglucosidase alfa.