Drugs › Hydrolytic lysosomal glycogen-specific enzyme
Brand name · Avalglucosidase alfa-ngpt
Nexviazyme: adverse event reports filed with FDA
843 reports list it as a suspect or interacting product, 2021–2026. Class: Hydrolytic lysosomal glycogen-specific enzyme.
- 843
- reports as suspect product
- 0% of all reports · about 175 a year
- 200
- reports, 12 months to June 2026
- 209 in the 12 months before
- 17.9%
- marked serious by the reporter
- 28.5% across the class
- 0.6%
- record death among outcomes, as reported
- 5 reports · not verified by FDA
Between September 2021 and June 2026, 843 adverse event reports received by FDA list the brand name Nexviazyme (avalglucosidase alfa-ngpt) as a suspect or interacting product. Reports that mention it only as a concomitant medication (3) are left out of every figure here.
In the 12 months to June 2026, 200 reports listed it, close to the 209 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 175 reports a year and 0% of the 20,646,523 reports in the database, and 29.7% of the reports for the hydrolytic lysosomal glycogen-specific enzyme class. How many people take it is not in the data, so a count is not a rate of occurrence.
The reactions recorded most often are drug specific antibody present (15.8%), off label use (9.5%) and weight increased (6.3%). A report can list several reactions, so shares add to more than 100%; 143 different terms appear across these reports. Drug specific antibody present is recorded in 15.8% of these reports, a larger share than in the median hydrolytic lysosomal glycogen-specific enzyme drug (9.6%).
17.9% of the reports are marked serious by the reporter (28.5% across the class); 0.6% record death among the outcomes and 9.7% record hospitalisation, as reported. 48% of the reports came from physicians, and the largest patient age group is 45 to 64 (21.6%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Nexviazyme reports recording the termmedian drug in hydrolytic lysosomal glycogen-specific enzyme
- Drug specific antibody present15.8%133
- Off label useused for a purpose or in a way not on the label9.5%80
- Weight increasedweight gain6.3%53
- Inappropriate schedule of product administrationthe product was taken at the wrong times4.7%40
- Weight decreasedweight loss4.7%40
- Fatiguetiredness3.6%30
- Illness3.6%30
- Dyspnoeashortness of breath3.4%29
- Pyrexiafever3.4%29
- Condition aggravatedthe condition being treated got worse2.7%23
- Headachehead pain2.6%22
- Nasopharyngitisa cold2.4%20
- Pruritusitching2.4%20
- Coughcough2.3%19
- Falla fall2.3%19
- Rashskin rash2.3%19
- Malaisegeneral feeling of being unwell2.1%18
- Pneumonialung infection2.1%18
- Nauseafeeling sick1.9%16
- Covid-19COVID-19 infection1.8%15
- Erythemaskin redness1.8%15
- Hypertensionhigh blood pressure1.7%14
- Pain in extremitypain in an arm or leg1.7%14
- Astheniaweakness or lack of energy1.5%13
- Incorrect dose administeredthe wrong dose was given1.5%13
- Influenzaflu1.5%13
- Painpain, site not specified1.5%13
- Chillschills or shivering1.4%12
- Infusion site extravasationinfusion fluid leaked into surrounding tissue1.4%12
Top 30 of 143 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 2 drugs in the hydrolytic lysosomal glycogen-specific enzyme class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 2,843 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 97.3% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Glycogen storage disease type ii | 543 | 64.4% |
The indication field is filled in by the reporter and is often blank; shares are of all 843 reports.
In context
| Measure | Nexviazyme | Hydrolytic lysosomal glycogen-specific enzyme | All reports |
|---|---|---|---|
| Reports as suspect product | 843 | 2,843 | 20,646,523 |
| Share of that pool | — | 29.7% | 0% |
| Reports, latest 12 months | 200 | — | 1,332,454 |
| Marked serious | 17.9% | 28.5% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 6 | 29 | 91 |
| Hospitalisation recorded, per 1,000 reports | 97 | 170 | 213 |
| Consumer-filed share | 16.1% | 26.2% | 45.8% |
| Top term, share of reports | Drug specific antibody present 15.8% | median 9.6% | 0% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the hydrolytic lysosomal glycogen-specific enzyme class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Lumizyme | brand | 2,000 | 100 | 33% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Nexviazyme reports
How many adverse event reports has FDA received for Nexviazyme?
843 reports list Nexviazyme as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 200 of them arrived in the latest 12 months. Another 3 list it only as a concomitant medication.
What reactions are recorded in Nexviazyme reports?
drug specific antibody present (15.8%), off label use (9.5%), weight increased (6.3%), inappropriate schedule of product administration (4.7%) and weight decreased (4.7%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Nexviazyme was responsible.
How serious are the reports?
17.9% are marked serious by the reporter. Among the outcomes recorded, 0.6% of reports include death and 9.7% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
physician (48%), other health professional (27.8%) and consumer or non-health professional (16.1%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Nexviazyme rising?
200 reports in the 12 months to June 2026, close to the 209 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Nexviazyme was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Nexviazyme?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Nexviazyme as a suspect or interacting product; reports listing it only as a concomitant medication (3) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.