Efgartigimod Expanded Access for Generalized Myasthenia Gravis

Inclusion Criteria:

- Patient is ≥18 years of age, at the time of signing the informed consent

- Patient has a diagnosis of MG (AChR-Ab seropositive or seronegative) with
generalized muscle weakness

- Patient has been vaccinated against COVID-19 or has had a negative COVID-19 test
result in the 2 weeks before enrollment

- Patient has documented IgG >6 g/L within one month of screening

- Patient agrees to contraceptive use consistent with local regulations and scientific
rationale regarding the methods of contraception and:

1. Male patients: must agree to use an acceptable method of contraception and to
not donate sperm from the time of providing informed consent until the end of
the program

2. Female patients: Women of childbearing potential must use a highly effective or
acceptable method of contraception and have a negative serum pregnancy test at
screening

- Patient provides signed informed consent, which includes compliance with the
requirements and restrictions listed in the informed consent form (ICF) and this
protocol

- Patients with a history of hepatitis B, hepatitis C, or HIV must have a documented
negative test for an active viral infection.

Exclusion Criteria:

- Patient has clinically significant uncontrolled active or chronic bacterial, viral,
or fungal infection at screening

- Patient has a known autoimmune disease that, in the opinion of the treating
physician, would interfere with an accurate assessment of clinical symptoms of gMG
or put the patient at undue risk

- Patient has a history of malignancy unless it is deemed to be cured by adequate
treatment with no evidence of recurrence for ≥3 years before the first
administration of the IMP. Patients with documentation of adequate treatment of the
following cancers can be included at any time: basal cell or squamous cell skin
cancer; carcinoma in situ of the cervix; carcinoma in situ of the breast; incidental
histological finding of prostate cancer (TNM stage T1a or T1b)

- Patient has clinical evidence of other significant serious diseases, has recently
had major surgery, or has any other condition that, in the opinion of the treating
physician, could put the patient at undue risk

- Patient may be excluded based upon review of clinical medical records and screening
clinical safety laboratory test results

- Patient has received a live or a live-attenuated vaccination during the month before
screening

- Patient is pregnant and/or lactating or intends to become pregnant during the
program or within 90 days after the last dose

- Patient is an unsterilized male who is sexually active while participating in the
program and does not intend to use effective methods of contraception during the
program through 90 days after the last dose or plans to donate sperm during the
program or through 90 days after the last dose.

- The patient has previously received rituximab, and the last rituximab dose was
received less than 6 months before the first dose of efgartigimod