FDA approves Ionis' Tryngolza (olezarsen) as first treatment for familial chylomicronemia syndrome

IONIS PHARMACEUTICALS INC

Phase 3 Balance trial: placebo-adjusted mean triglyceride reduction 42.5% at 6 months (p=0.0084), 57% at 12 months.
Acute pancreatitis events: 1 patient (5%) on Tryngolza vs 7 patients (30%) on placebo over 12 months.
Most common adverse reactions: injection site reactions (19% vs 9%), decreased platelets (12% vs 4%), arthralgia (9% vs 0%).
U.S. launch expected before year-end; first of four independent launches planned over next three years.
FCS affects up to ~3,000 people in U.S.; Tryngolza is self-administered monthly via auto-injector.

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