The approval follows a positive opinion of the Committee for Medicinal Products for Human Use.

“Tryngolza is the next step in our support for the FCS community in Europe. It has a strong safety and efficacy profile, with significant reductions in triglyceride levels and a notable decrease in acute pancreatitis events, which impact morbidity, mortality, and quality of life. This builds on our commitment to FCS that began with Waylivra (volanesorsen), the only approved treatment for FCS in Europe until now. With the European Commission’s approval of Tryngolza for FCS, we are looking forward to providing this therapy to eligible patients with this rare and debilitating condition across the EU,” says Lydia Abad-Franch, Head of Research, Development, and Medical Affairs (RDMA) and Chief Medical Officer at Sobi.

The Phase 3 Balance study

The approval is based on positive data from the Phase 3 Balance study, in which Tryngolza 80 mg demonstrated a statistically significant reduction in fasting triglyceride levels at six months that was sustained through 12 months. Additionally, Tryngolza demonstrated a substantial and clinically meaningful reduction in acute pancreatitis events over 12 months. Tryngolza showed a favourable safety and tolerability profile.

Sobi has exclusive rights to commercialize Tryngolza in countries outside the U.S., Canada and China.

Tryngolza is also being evaluated in patients with sHTG with triglyceride levels ≥500 mg/dL (5.65 mmol/L), and positive topline results from the Phase 3 studies were announced in September 2025.