Ionis Pharmaceuticals (NASDAQ: IONS) announced FDA approval of TRYNGOLZA™ (olezarsen), the first-ever treatment for adults with familial chylomicronemia syndrome (FCS). The drug, administered monthly via auto-injector, demonstrated a 42.5% placebo-adjusted mean reduction in triglyceride levels at six months and 57% at 12 months in Phase 3 Balance trial. TRYNGOLZA significantly reduced acute pancreatitis events, with only one episode in the treatment group versus 11 episodes in the placebo group.
The treatment showed a favorable safety profile and will be available in the U.S. before year end. This approval marks Ionis's evolution into a commercial-stage biotechnology company, with TRYNGOLZA being the first of four planned launches over the next three years.
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