Arrowhead bets on Redemplo label expansion, targeting Q2 2027 launch in broader triglyceride market

Arrowhead Pharmaceuticals is positioning Redemplo (plozasiran) to move beyond its first, narrow indication. Alongside results for the year ended 30 September 2026, published on 12 November 2026, the company said it has filed a supplemental new drug application for severe hypertriglyceridemia (sHTG) and is aiming for a US launch in the second quarter of 2027. That date is Arrowhead's own target, not an FDA decision.

The filing has been accepted into the FDA's STAR pilot programme. The information available to CompePharma does not explain how the pilot works or whether it changes the review timetable, so its practical effect on timing is unclear.

Arrowhead says the application rests on two Phase 3 studies, SHASTA-3 and SHASTA-4, in which triglyceride levels fell by about 80%. Endpoints, comparators and safety data were not provided, so the strength of the package cannot be judged from the company's summary.

The commercial case starts with the current indication, familial chylomicronemia syndrome (FCS), where Arrowhead says the US launch is growing. It gave no sales figures in the material reviewed. It did cite access milestones: coverage of 160 million US lives, reimbursement in Germany, a UK marketing authorisation from the MHRA and a NICE recommendation. Reimbursement terms and the content of the NICE guidance were not disclosed.