Neurology
Generalized myasthenia gravis: the approved drugs compared for prescribers
Vyvgart side by side on what each first fill waits on, what the label requires you to monitor and what an insurer asks to see, with FDA decisions, label changes and open trials for generalized myasthenia gravis.
1prescribing companion
2FDA decisions pending
117open or opening studies
November 7, 2026last checked
The drugs side by side
Each cell is a summary of that drug's prescribing companion, which carries the full detail and a source on every line. Insurer thresholds are one public policy shown as an example; plans differ.
| Vyvgartefgartigimod alfa | |
|---|---|
| Label dated | May 13, 2026 |
| Starting dose | 10mg/kg IV over 1 hour once weekly for 4 weeks; 1,200mg per infusion at 120kg or more. Given by a healthcare professional. |
| Dispensing gate | No REMS. Prior authorization, a site of care (infusion center, office, home nurse, or prefilled syringe self-injection after specialty pharmacy training), and no active infection on each dose day |
| Required monitoring | Hypersensitivity observation for 1 hour after IV and at least 30 minutes after SC; infection check before each dose; vaccine review before each new cycle; no scheduled labs |
| Example PA threshold | FEP example: age 18 or older, anti-AChR positive in a policy written before the May 2026 all-gMG label, MGFA II to IV, MG-ADL 5 or higher or QMG above 9, one failed AChE inhibitor or immunosuppressant, IgG 6g/L or higher |
| Support line | My VYVGART Path, 1-833-697-2841, Monday to Friday 8 AM to 8 PM ET, Nurse Case Manager, co-pay to $0 up to $25,000 a year for commercial plans, Quick Start supply for access delays |
Vyvgart efgartigimod alfa
- Label dated
- May 13, 2026
- Starting dose
- 10mg/kg IV over 1 hour once weekly for 4 weeks; 1,200mg per infusion at 120kg or more. Given by a healthcare professional.
- Dispensing gate
- No REMS. Prior authorization, a site of care (infusion center, office, home nurse, or prefilled syringe self-injection after specialty pharmacy training), and no active infection on each dose day
- Required monitoring
- Hypersensitivity observation for 1 hour after IV and at least 30 minutes after SC; infection check before each dose; vaccine review before each new cycle; no scheduled labs
- Example PA threshold
- FEP example: age 18 or older, anti-AChR positive in a policy written before the May 2026 all-gMG label, MGFA II to IV, MG-ADL 5 or higher or QMG above 9, one failed AChE inhibitor or immunosuppressant, IgG 6g/L or higher
- Support line
- My VYVGART Path, 1-833-697-2841, Monday to Friday 8 AM to 8 PM ET, Nurse Case Manager, co-pay to $0 up to $25,000 a year for commercial plans, Quick Start supply for access delays
FDA decisions for generalized myasthenia gravis
From the Trial Friend FDA decision calendar, which records each date from the sponsor's or the FDA's own announcement.
- November 2026Cemdisiran, NDA, RegeneronPending
- Date not disclosedGefurulimab, BLA, AstraZeneca (Alexion)Pending
Recent label changes
What changed in each label revision, from the FDA's approval letters and the labels' own revision lists.
- May 2026Vyvgart. The approved use widened from adults with AChR antibodies to all adults with generalized myasthenia gravis, for both Vyvgart and Vyvgart Hytrulo. The label added a trial in 119 adults without AChR antibodies. The dose and the rules for treatment cycles did not change with this approval. FDA letter
- February 2026Vyvgart. The FDA required new safety wording on the risk of severe worsening of CIDP symptoms after starting Vyvgart Hytrulo. The change sits in the CIDP dosing section and did not touch myasthenia gravis dosing. FDA letter
- October 2025Vyvgart. The FDA removed the statement that cycles started sooner than 50 days after the previous start had not been shown safe. The label added a study of 60 patients who began cycles 7 to 28 days after their last dose. FDA letter
- April 2025Vyvgart. The Vyvgart Hytrulo prefilled syringe was approved, and the label began allowing patients or caregivers to give it at home after training. FDA letter
- August 2024Vyvgart. The FDA approved new vaccination wording in the dose and warnings sections of both labels. FDA letter
- July 2024Vyvgart. Details of the pregnancy exposure registry were added to the Vyvgart label. FDA letter
Open trials
117
Screen a patient against themstudies listing Myasthenia Gravis are recruiting or about to open on ClinicalTrials.gov
Counted live, at most once a day
A reference for licensed professionals, checked on November 7, 2026. Labels and plan policies change; the label on DailyMed and the plan's current policy govern. Not medical advice. For patients: the Generalized myasthenia gravis page and the first 90 days pages for Vyvgart.