Ionis receives FDA Fast Track designation for olezarsen in patients with familial chylomicronemia syndrom

• FCS is a rareand debilitating genetic disease often leading to significant risk of acute, potentially fatal pancreatitis
• If approved, olezarsen would be the first approved treatment for FCS in the U.S.

CARLSBAD, Calif., Jan. 31, 2023 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. IONS today announced that the U.S. Food and Drug Administration (FDA) has granted olezarsen Fast Track designation for the treatment of familial chylomicronemia syndrome (FCS).

FCS is a debilitating genetic disease characterized by severely high levels of plasma triglyceridesand a risk of unpredictable and potentially fatal acute pancreatitis. In addition to acute pancreatitis, FCS patients are at risk of chronic complications due to permanent organ damage, including chronic pancreatitis and type 3c diabetes. There are currently no approved therapies for the treatment of FCS in the U.S.

Fast Track designation is designed to expedite the FDA's review of innovative, new drugs that demonstrate the potential to address unmet medical need.