Avalglucosidase Alfa French Post-trial Access for Participants With Pompe Disease (PTA Avalglucosidase)

Inclusion Criteria:

• Patient with LOPD or IOPD who has previously completed Study EFC14028, LTS13769, orACT14132 in France, and reimbursement for avalglucosidase alfa is not yet granted inFrance.

• The patient and/or their parent/legal guardian is willing and able to provide signedinformed consent, and the patient, if <18 years of age, is willing to provide assentif deemed able to do so.

• The patient (and patient's legal guardian if patient is <18 years of age) must havethe ability to comply with the clinical protocol.

• The patient, if female and of childbearing potential, must have a negative pregnancytest result [urine beta-human chorionic gonadotropin (β-HCG)] at enrollment.

• Sexually active female patients of childbearing potential and male patients arerequired to practice true abstinence in line with their preferred and usuallifestyle or to use 2 acceptable effective methods of contraception.

Exclusion Criteria:

• Patient with life-threatening hypersensitivity (anaphylactic reaction) to one ofavalglucosidase alfa's excipients.

• Patient who permanently discontinued avalglucosidase alfa in a previous clinicalstudy

• Pregnant or breastfeeding female patient

• The patient is concurrently participating in another clinical study ofinvestigational treatment.

• The patient, in opinion of the Investigator, is unable to comply with therequirements of the study.

• The patient has clinically significant organic disease (with the exception ofsymptoms relating to Pompe disease), including clinically significantcardiovascular, hepatobiliary, pulmonary, neurologic, or renal disease, or othermedical condition, serious intercurrent illness, or extenuating circumstance that,in the opinion of the Investigator, precludes participation in the study orpotentially decreases survival.

• Individuals accommodated in an institution because of regulatory or legal order;prisoners, or patients who are legally institutionalized.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.