Shots:Ionis has reported P-III (CORE: n=617 & CORE2: n=446) trials data assessing olezarsen (50 or 80mg, SC, Q4W) vs PBO for 12mos. in adults with severe hypertriglyceridemia (sHTG); the US FDA’s sNDA submission expected by year endBoth studies met their 1EP, with CORE showing reduction in fasting triglycerides by 72% (80mg) & 63%…
Shots: The US FDA has approved Tryngolza (80mg, QM, self-administered via an auto-injector) as an adj. for reducing triglycerides (TG) in FCS patients, based on a P-III (BALANCE) study. Further submission is under review in the EU, with more filings planned The P-III study involved FCS patients with fasting TG levels of ≥880mg/dL. Trial showed…

