The Approach Open Label Study: A Study of Volanesorsen (Formerly IONIS-APOCIIIRx) in Patients With Familial Chylomicronemia Syndrome

Inclusion Criteria:

• Must give written informed consent to participate in the study (signed and dated) and any authorization required by law
• Able and willing to participate in a 65-week study

Group 1 and 2:

• Satisfactory completion of ISIS 304801-CS6 or ISIS 304801-CS16 (index studies) with an acceptable safety profile, per Sponsor and Investigator judgment

Group 3:

• Patients who did not participate in the CS6 or CS16 index studies and meet additional inclusion criteria of Familial Chylomicronemia Syndrome (FCS) may enroll in the study.
• History of chylomicronemia
• A diagnosis of Familial Chylomicronemia Syndrome (Type 1 Hyperlipoproteinemia)
• Fasting triglycerides ≥ 750 mg/dL (8.4mmol/L) at Screening

Exclusion Criteria:

• Unwilling to comply with lifestyle requirements for the duration of the study

Group 1 and 2:

• Have any new condition or worsening of existing condition which in the opinion of the Investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in or completing the study.

Group 3:

• Diabetes mellitus if newly diagnosed or if HbA1c ≥ 9.0%
• Active pancreatitis within 4 weeks of screening
• Acute Coronary Syndrome within 6 months of screening
• Major surgery within 3 months of screening
• Treatment with Glybera therapy within 2 years of screening
• Have any other conditions in the opinion of the investigator which could interfere with the patient participating in or completing the study.