Overview
- EMA’s human medicines committee issued a positive opinion recommending EU marketing authorisation for Redemplo, also known as plozasiran.
- Regulators cited a phase 3 trial in 75 adults that cut triglycerides by about 80% versus 17% with placebo and showed fewer acute pancreatitis events.
- Plozasiran lowers triglycerides by blocking APOC3 production in the liver, which speeds the breakdown and clearance of fat from the blood.
- The medicine comes as a 25 mg pre-filled syringe and is injected under the skin every three months as an add-on to a low-fat diet.
- If the Commission grants approval, each country will decide price and coverage, and doctors can prescribe without genetic proof of FCS, which could widen access.