Extension Study of TKT028 Evaluating Safety and Clinical Outcomes of Replagal® in Adult Patients With Fabry Disease

HGT-REP-060 was designed to provide participants who participated in TKT028 an additional 52
weeks of treatment with Replagal at the standard dose of 0.2 milligram per kilogram (mg/kg)
every other week (EOW) to assess the effect of continued Replagal therapy on long-term safety
and clinical outcomes for this participant population.

Inclusion Criteria:

- Complete all study requirements and assessments for Study TKT028 less than 30 days
(+/- 7 days) prior to the first dose in this extension protocol

- Voluntarily signed an Institutional Review Board/Independent Ethics Committee-
approved informed consent form after all relevant aspects of the study have been
explained and discussed.

- Has received and tolerated at least 80% of the total planned Replagal infusions in
Study TKT028

- Female participants of child-bearing potential must agree to use a medically
acceptable method of contraception at all times during the study and must have a
negative pregnancy test at the time of study entry and as required throughout
participation in study

Exclusion Criteria:

- Has received treatment with any investigational drug (other than Replagal) or device
within 30 days prior to study entry.

- Is unable to comply with the protocol, (eg, is unable to return for safety
evaluations, or is otherwise unlikely to complete the study), as determined by the
Investigator

- Has a positive test for hepatitis B surface antigen (HBsAg), hepatitis C(HCV)
antibody, or human immunodeficiency virus (HIV) antibody

- Is pregnant or lactating

- Is morbidly obese, defined as body mass index (BMI) >39 kg/m2

- Has any safety or medical issues, as assessed by the Investigator, that contraindicate
participation in the study (eg, has experienced an adverse reaction to treatment with
Replagal or has a known hypersensitivity to any of the components of Replagal