Arrowhead Pharmaceuticals Presents New Pivotal Phase 3 Data at ESC 2024 from PALISADE Study of Plozasiran in Patients with Familial Chylomicronemia Syndrome
Arrowhead Pharmaceuticals announces positive Phase 3 PALISADE study results for plozasiran in patients with familial chylomicronemia syndrome (FCS), showing significant reductions in triglycerides and risk of acute pancreatitis, with plans to file a New Drug Application with the FDA by year-end 2024.
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Arrowhead Pharmaceuticals wins FDA breakthrough-therapy designation for plozasiran, aimed at reducing triglycerides in adults with familial chylomicronemia syndrome, a rare genetic disease causing high triglyceride levels and potential fatal pancreatitis.
FDA grants Breakthrough Therapy designation to plozasiran for reducing triglycerides in adults with familial chylomicronemia syndrome (FCS). Plozasiran, an RNA interference therapeutic, targets apolipoprotein C-III to manage triglyceride levels via subcutaneous injection. Results from the PALISADE trial indicate significant triglyceride reduction and lower pancreatitis risk with similar safety profiles. Arrowhead plans to submit a New Drug Application by end of 2024.
FDA grants breakthrough therapy designation to Arrowhead Pharmaceuticals’ plozasiran, an RNAi therapeutic for familial chylomicronemia syndrome (FCS), aiming to reduce triglycerides by targeting apolipoprotein C-III (APOC3). The designation expedites drug development and review for serious conditions. Plozasiran has shown promising results in clinical studies and is part of the SUMMIT programme, with a planned FDA submission by end of 2024.
Arrowhead Pharmaceuticals announces FDA Breakthrough Therapy designation for plozasiran to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS), a rare genetic disease with no approved treatments in the U.S.
Arrowhead Pharmaceuticals granted breakthrough therapy designation by FDA for plozasiran, an RNAi therapeutic showing promising results in reducing triglycerides and atherogenic lipoproteins. Intended for use with a healthy diet in adults with familial chylomicronaemia syndrome (FCS), plozasiran also reduces apolipoprotein C-III (APOC3) production. Arrowhead aims to submit a new drug application to the FDA by year-end.
Arrowhead Pharmaceuticals received FDA Breakthrough Therapy designation for plozasiran, an investigational drug for familial chylomicronemia syndrome (FCS), showing an 80% reduction in triglycerides and an 83% decrease in acute pancreatitis risk. No FDA-approved treatments currently exist for FCS. Arrowhead plans to submit a New Drug Application by year-end 2024.
FDA grants breakthrough therapy designation to Arrowhead Pharmaceuticals’ plozasiran, an RNAi therapeutic for reducing triglycerides in adults with familial chylomicronemia syndrome (FCS). Plozasiran targets apolipoprotein C-III (APOC3) and has shown promising results in clinical studies. Arrowhead plans to submit a new drug application by end of 2024.
PALISADE Phase 3 results show plozasiran reduced triglycerides by 80% and acute pancreatitis risk by 83% in FCS patients. FDA granted Breakthrough Therapy designation to plozasiran for reducing triglycerides in FCS adults. Arrowhead plans to submit a New Drug Application by year-end 2024.
The FDA granted breakthrough therapy designation to Arrowhead Pharmaceuticals’ plozasiran for reducing triglycerides in familial chylomicronemia syndrome (FCS) patients, positioning it to compete with Ionis Pharmaceuticals’ olezarsen. Plozasiran, an RNA interference therapeutic, aims to lower triglycerides by inhibiting apolipoprotein C-III production. The decision was based on phase 3 PALISADE trial data showing an 80% triglyceride reduction and an 83% decrease in acute pancreatitis risk. Arrowhead plans to submit a new drug application to the FDA by year-end.
Arrowhead Pharmaceuticals announces positive Phase 3 PALISADE study results for plozasiran in patients with familial chylomicronemia syndrome (FCS), showing significant reductions in triglycerides and risk of acute pancreatitis, with plans to file a New Drug Application with the FDA by year-end 2024.
PALISADE Phase 3 results show plozasiran reduced triglycerides by 80% and acute pancreatitis risk by 83% in FCS patients. FDA granted Breakthrough Therapy designation to plozasiran for reducing triglycerides in FCS adults. Arrowhead plans to submit a New Drug Application by year-end 2024.
Arrowhead Pharmaceuticals receives FDA breakthrough-therapy designation for plozasiran, intended to reduce triglycerides in adults with familial chylomicronemia syndrome, a rare genetic disease. No approved treatments exist for this condition in the U.S. A Phase 3 study demonstrated plozasiran's efficacy in significantly lowering triglycerides and reducing pancreatitis risk.