Regulatory Daily Summary
Regulatory Daily Summary: What Happened on October 28, 2026
Arrowhead wins UK authorization for Redemplo, with NICE backing
The White House also prevailed in a dispute over the scope of the COINS rule.
Today in brief
Arrowhead Pharmaceuticals secured UK authorization for Redemplo to lower triglycerides in adults with familial chylomicronemia syndrome. NICE recommended NHS funding in England and Wales for eligible adults with genetically confirmed disease whose condition isn’t adequately controlled by diet and standard treatments.1 The White House prevailed over Treasury and HHS in a dispute over the COINS rule, whose scope the National Security Council broadened.2
Redemplo gains UK authorization and a recommendation for NHS funding
The UK Medicines and Healthcare products Regulatory Agency authorized Arrowhead’s Redemplo, or plozasiran, as an addition to diet to lower triglycerides in adults with familial chylomicronemia syndrome, a rare metabolic condition associated with very high triglyceride levels.1 The authorization applies across the UK. NICE’s recommendation guides NHS care in England and Wales, covering adults with genetically confirmed disease whose condition remains inadequately controlled by diet and standard triglyceride-lowering treatments.1 NICE’s recommendation is subject to a commercial arrangement. Northern Ireland has a separate validation process, while Scotland requires an independent reimbursement appraisal.1
The authorization drew on PALISADE, a Phase 3 placebo-controlled study of 75 adults. Its primary measure compared the median percentage change from baseline in fasting triglycerides against placebo at month 10.1 Arrowhead’s Europe head, Graham Skarnvad, said the company is focused on making plozasiran available in more European countries over the coming months.1