Balance Efficacy & Safety
The pivotal Balance trial
Safety and efficacy of Tryngolza were evaluated in adults with familial chylomicronemia syndrome in the Balance trial: a randomised, placebo-controlled, double-blind phase 3 clinical trial.1,2
MOA & pharmacodynamics
Tryngolza is a GalNAc3-conjugated antisense oligonucleotide inhibitor of apolipoprotein C-III (apoC-III) production1
GalNAc3-conjugate enables targeted delivery to the liver, where APOC3 mRNA is generated.1,2 ApoC-III acts on the lipoprotein lipase (LPL) -dependent pathway and LPL-independent pathways.3
Safety profile
Tryngolza demonstrated a well-tolerated safety profile in participants with familial chylomicronemia syndrome (FCS)1,2
The safety of Tryngolza was evaluated in 43 participants who received at least 1 dose of treatment; 23 participants in the Balance trial received placebo.1,2
Tryngolza▼(olezarsen) is indicated as an adjunct to diet in adult patients for the treatment of genetically confirmed familial chylomicronemia syndrome (FCS).
▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. See section 4.8 of the SmPC for how to report adverse reactions.
Healthcare professionals should report any suspected adverse reactions via their national pharmacovigilance reporting system. Suspected adverse reactions should also be reported to Sobi via email at [email protected].
This material is intended for an international audience of healthcare professionals and is based on the Tryngolza Summary of Product Characteristics (SmPC) approved for use in the European Economic Area (EEA). SmPC/Prescribing information, product availability, and pricing/reimbursement conditions may vary by country. Before prescribing, always refer to locally approved SmPC and/or prescribing information.
The Sobi Scientific Information Department is at your disposal for any additional information: [email protected].
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All rights reserved.
SOBI is a trademark of Swedish Orphan Biovitrum AB (publ).
TRYNGOLZA is a registered trademark of Arexis AB, a Sobi company, and Ionis Pharmaceuticals, Inc.
TRYNGOLZA (olezarsen) – Discovered by Ionis Pharmaceuticals, Inc.
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