Open-Label Expanded Access Treatment With Pegunigalsidase Alfa for Fabry Disease Patients

Open to people ages 18 years and up

• In the opinion of the Treating Physician, the patient cannot be adequately treated with any FDA approved drugs for Fabry and is not able to enroll in any current clinical trial for Fabry disease.
• Patient (or legal guardian) is able to sign an informed consent prior to treatment.
• A documented diagnosis of Fabry disease.
• Preferably two, but at minimum 1, historical serum creatinine evaluations in the last 2 years with the latest value within the last 6 months.
• Female patients and male patients whose co-partners are of child-bearing potential agree to use a medically acceptable method of contraception, not including the rhythm method. Acceptable methods of contraception include hormonal products, intrauterine device, or male or female condoms. Contraception should be used for 90 days after treatment discontinuation.

• Patients enrolled and currently treated in Study PB-102-F20, and patients enrolled and currently treated in Extension Study PB-102-F60
• Patients who currently are on treatment under any other ongoing clinical trials of PRX-102
• History of Type 1 (anaphylaxis or anaphylactoid like) life-threatening hypersensitivity during previous exposure to other ERTs which could not be handled with medication
• Women who are breastfeeding may not participate unless they agree to stop breastfeeding.
• Women who are currently pregnant.