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TRYNGOLZA® (olezarsen) recommended for EU approval by CHMP for familial chylomicronemia syndrome (FCS)
Sobi® (STO: SOBI) and Ionis Pharmaceuticals, Inc. today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion of TRYNGOLZA® (olezarsen) as an adjunct to diet in adult patients for the treatment of genetically confirmed familial chylomicronemia syndrome (FCS). The positive opinion is now referred to the European Commission (EC) for an approval decision, which is expected by Q4 2025.
About this update from Swedish Orphan Biovitrum Ab
[{"type":"list","items":[{"val":[{"type":"text","content":"Recommendation based on Phase 3 Balance results, which showed a significant reduction of triglycerides and substantial reduction of acute pancreatitis events with TRYNGOLZA","length":172,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":172,"olType":false},{"type":"list","items":[{"val":[{"type":"text","content":"European Commission decision expected by Q4 2025","length":48,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":48,"olType":false},{"type":"text","content":"STOCKHOLM, July 25, 2025 /PRNewswire/ -- Sobi® (STO: SOBI) and Ionis Pharmaceuticals, Inc. today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion of TRYNGOLZA® (olezarsen) as an adjunct to diet in adult patients for the treatment of genetically confirmed familial chylomicronemia syndrome (FCS). The positive opinion is now referred to the European Commission (EC) for an approval decision, which is expected by Q4 2025.","length":513,"tagName":"p"},{"type":"text","content":"Lydia Abad-Franch, MD, MBA, Head of Research, Development, and Medical Affairs (RDMA) and Chief Medical Officer at Sobi said "The approval recommendation brings us one step closer toward delivering TRYNGOLZA to people living with FCS in the EU and is a testament to our long-standing support for the FCS community. Patients with FCS suffer from complications such as acute pancreatitis. These are very severe events, often requiring intensive care and sometimes causing multiorgan failure as well as increasing morbidity and mortality. We believe TRYNGOLZA has the potential to be an important treatment for people living with this rare and serious disease, and we look forward to the final decision from the EC later this year."","length":739,"tagName":"p"},{"type":"text","content":""Building on the strong early launch of TRYNGOLZA in the U.S., the positive CHMP opinion advances our commitment to expand access to TRYNGOLZA globally," said Brett P. Monia, Ph.D., chief executive officer of Ionis. "TRYNGOLZA has demonstrated significant reductions in triglycerides and substantial reductions in acute pancreatitis events with favourable safety and tolerability. With this robust clinical profile, combined with Sobi's deep commercial market...