Nexviadyme (avalglucosidase alfa)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- avalglucosidase alfa
- Company
- Sanofi B.V.
- Status
- Authorised
- Therapeutic area
- Glycogen Storage Disease Type II
- CHMP opinion
- Thu 11 Nov 2021
- EU approval
- Fri 24 Jun 2022
- Designations
- Additional monitoring
- Application
- EMEA/H/C/005501
- ATC
- A16
- Official record
- www.ema.europa.eu
Indication
Nexviadyme (avalglucosidase alfa) is indicated for long-term enzyme replacement therapy for the treatment of patients with Pompe disease (acid ?-glucosidase deficiency).
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.