The Medicines and Healthcare products Regulatory Agency (MHRA) has today 10 April 2026, approved olezarsen (Tryngolza) to help treat adults with familial chylomicronemia syndrome (FCS).
FCS is an inherited disease that gives rise to abnormally high levels of fats called triglycerides in the blood. This can lead to inflammation of the pancreas, causing severe pain, lasting damage to the pancreas, and can be life threatening.
Olezarsen is administered as an injection under the skin, usually into the stomach area, the front of the thighs, or the back of the upper arms.
In a main study involving 66 adults with FCS, olezarsen was shown to significantly reduce triglyceride levels in the blood. All patients followed a controlled diet and received either Tryngolza or a placebo.
After 6 months, patients treated with Tryngolza saw an average reduction in triglycerides of 32%, compared with an average increase of 12% in those given placebo. These benefits were maintained and further improved after one year, with fewer cases of acute pancreatitis reported in patients taking Tryngolza.
Julian Beach, Interim Executive Director of Healthcare Quality and Access at the MHRA, said
“This approval provides a new treatment option for adults living with familial chylomicronemia syndrome, an inherited condition that can lead to inflammation of the pancreas, causing severe pain and potentially life-threatening complications.
“As with all medicines, we will continue to closely monitor the safety and effectiveness of olezarsen as it is used more widely.”
Notes to editors
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The approval was granted on 10/04/2026 to Swedish Orphan Biovitrum AB (publ)
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This product was submitted and approved via IRP Route B
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More information can be found in the Summary of Product Characteristics and Patient Information Leaflets which will be published on the MHRA Products website within 7 days of approval.
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The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
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The MHRA is an executive agency of the Department of Health and Social Care.
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