NICE Backs Tryngolza for FCS, Giving Sobi a Monthly Successor to Its Own Waylivra

NICE has issued final draft guidance recommending Tryngolza (olezarsen) for adults with genetically confirmed familial chylomicronaemia syndrome (FCS) in England and Wales, only when diet and conventional triglyceride-lowering treatment such as statins and fibrates have not worked, Sobi UK said on 1 October 2026. Sobi sells Tryngolza outside the US, except in Canada and China, under licence from Ionis.
In the Phase 3 BALANCE study, fasting triglycerides fell 32% at six months on olezarsen 80 mg (n=22) and rose 12% on placebo (n=23), a placebo-adjusted difference of 43.5%, widening to 59.4% at 12 months. Acute pancreatitis events fell over 12 months. The most common adverse reactions were injection-site redness (17%), headache (16%), joint pain (15%) and vomiting (10%). It is given every four weeks.
About 114 people are diagnosed with FCS in the UK, though the condition is thought to be underdiagnosed. Olezarsen is an RNA-targeted medicine that lowers production of apolipoprotein C-III in the liver.
Sobi already sells Waylivra (volanesorsen), another apoC-III antisense drug, which NICE recommended in 2020 in its highly specialised technologies programme for genetically confirmed FCS at high risk of pancreatitis, after an initial negative draft. Waylivra starts weekly, moves to every two weeks, and very commonly lowers platelet counts, which requires enhanced monitoring.

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Sobi is moving its FCS franchise to a less frequent, better-tolerated drug, and NICE has accepted it on broader terms than the one it replaces.

A successor to Sobi’s own drug. Both medicines hit the same target, but Tryngolza is monthly and its common side effects do not include the platelet problem that defines Waylivra’s monitoring. In NICE’s scoping consultation, Sobi itself highlighted Waylivra’s restricted recommendation and its thrombocytopenia burden.
Broader terms, same genetic gate. The new recommendation drops the high-risk-of-pancreatitis condition attached to Waylivra, but both still require genetic confirmation. Australia’s label for Arrowhead’s Redemplo, by contrast, also covers clinically diagnosed FCS, which matters in a condition thought to be underdiagnosed.
The price now sets Arrowhead’s benchmark. NICE lists olezarsen as a standard technology appraisal (ID6585), whereas Waylivra went through the highly specialised programme, where the cost-effectiveness bar is higher. Redemplo, dosed every three months, would face that reference if it seeks NICE approval.