Volanesorsen Early Access Program for Patients With Familial Chylomicronemia Syndrome (FCS)

• Patients who participated in the APPROACH Open Label trial, must have completed the open label extension trial for volanesorsen for a length of time consistent with the study protocol (≥ 1 year). Patients in the APPROACH open Label trial for less than a year require approval from Akcea to participate in the EAP. Patients who did not participate in the APPROACH open label trial require approval from Akcea for entry into EAP.
• Patients not participating in the APPROACH open label trial must have a diagnosis of FCS as determined by the participating physician, as outlined in the Volanesorsen EAP protocol. Akcea will review each application to determine eligibility.
• Male patients and female patients of childbearing potential must continue to use appropriate contraception with their partners, or refrain from sexual activity

Exclusion Criteria:

• Patients who have any new conditions or worsening of existing conditions which in the opinion of the Physician would make the patient unsuitable for treatment with volanesorsen.
• Volanesorsen naïve patients with baseline platelet values ≤ 140,000/mm3
• Patients not willing to adhere to mandatory blood draws for platelet monitoring
• Patients who in the opinion of Akcea's medical team, are not eligible candidates for volanesorsen therapy.
• Any patient who plans to or becomes pregnant.
• Any patient who was withdrawn from the APPROACH open label study due to a serious adverse event related to volanesorsen therapy.