Arrowhead Pharmaceuticals (ARWR) said late Friday that its new drug application for plozasiran to treat patients with familial chylomicronemia syndrome was accepted by the US Food and Drug Administration.
The FDA has set a Prescription Drug User Fee Act action date of Nov. 18 and does not currently plan to convene an advisory committee meeting.
The new drug application is based on positive data from the phase 3 Palisade study that showed plozasiran met the primary goal along with key secondary endpoints including reductions in triglycerides, apolipoprotein C-III and the incidence of acute pancreatitis, Arrowhead added.
Chief Executive, Chris Anzalone, said Arrowhead is focused on ensuring a successful commercial launch in 2025, pending FDA review and approval.
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