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Arrowhead files plozasiran sNDA for severe hypertriglyceridemia under FDA STAR pilot

🇺🇸 Arrowhead Pharmaceuticals, Inc. (ARWR) · Thu 12 Nov 2026

In its fiscal 2026 results, Arrowhead reported growth in the US Redemplo launch for FCS and an sNDA for sHTG, with a US launch targeted for Q2 2027.

Arrowhead Pharmaceuticals reported results for the fiscal year ended 30 September 2026 on 12 November 2026. The company said the US launch of Redemplo (plozasiran) in familial chylomicronemia syndrome (FCS) is growing.

The company has submitted a supplemental new drug application (sNDA) for plozasiran in severe hypertriglyceridemia (sHTG). The submission has been accepted into the US Food and Drug Administration's STAR pilot programme. Arrowhead is targeting a potential US launch in the second quarter of 2027.

Arrowhead said the filing is supported by Phase 3 SHASTA-3 and SHASTA-4 data, which showed triglyceride reductions of about 80%. The summary does not provide further trial detail, such as endpoints, comparators or safety findings.

On access, Arrowhead said Redemplo has reached 160 million covered lives in the US. It also cited reimbursement in Germany, a marketing authorisation from the UK's MHRA and a recommendation from NICE. The source does not give details of the reimbursement terms or the NICE guidance.

What it means for your team

  • Regulatory teams should note the sNDA's acceptance into the FDA STAR pilot, though the available information does not describe how the programme works or what it means for the review timeline.
  • Market-access teams can track the stated coverage of 160 million US lives, German reimbursement and the NICE recommendation as early signals of payer uptake in FCS.
  • A move into the broader sHTG population would widen the potential patient base; the Q2 2027 launch is a company target, not an FDA decision.

Company's press release (SEC filing): Arrowhead Pharmaceuticals, Inc. ↗

Article written by VigiEye from the official source (Arrowhead Pharmaceuticals, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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