Olezarsen (Tryngolza) Approved for Familial Chylomicronemia Syndrome
Summary
The MHRA has approved olezarsen (Tryngolza) for the treatment of familial chylomicronemia syndrome (FCS) in adults. The approval was granted on 10 April 2026 to Swedish Orphan Biovitrum AB (publ) via IRP Route B. In a study of 66 adults, patients treated with Tryngolza showed an average 32% reduction in triglycerides after 6 months, compared with a 12% average increase in the placebo group, with benefits maintained and further improved after one year.
What changed
The MHRA has granted approval for olezarsen (Tryngolza), a subcutaneous injection medication developed by Swedish Orphan Biovitrum AB, for the treatment of familial chylomicronemia syndrome (FCS) in adults. FCS is an inherited condition causing abnormally high triglyceride levels that can lead to pancreatitis. Clinical trial data demonstrated significant efficacy, with patients experiencing a 32% average reduction in triglycerides after 6 months compared to a 12% average increase in the placebo group, with sustained benefits observed at one year and fewer acute pancreatitis cases reported.
For pharmaceutical companies, this represents a new approved treatment option for a rare disease indication. Healthcare providers treating FCS patients now have an additional therapeutic option approved by the MHRA. The approval via IRP Route B indicates this followed an expedited review pathway. The MHRA will continue monitoring the safety and effectiveness of olezarsen as it is used more widely.
What to do next
- Monitor for updates
- Review Summary of Product Characteristics and Patient Information Leaflets when published on MHRA Products website within 7 days
Archived snapshot
Apr 12, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Press release
MHRA approves olezarsen (Tryngolza) for the treatment of familial chylomicronemia syndrome
MHRA approves olezarsen (Tryngolza) for the treatment of familial chylomicronemia syndrome
From: Medicines and Healthcare products Regulatory Agency Published 10 April 2026
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
- The approval was granted on 10/04/2026 to Swedish Orphan Biovitrum AB (publ)
- This product was submitted and approved via IRP Route B
- 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.
- 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.
- The MHRA is an executive agency of the Department of Health and Social Care.
- For media enquiries, please contact newscentre@mhra.gov.uk or call 020 3080 7651.
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Published 10 April 2026
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