Arrowhead receives EC approval for REDEMPLO

• Arrowhead Pharmaceuticals (NASDAQ:ARWR) has received formal European Commission marketing authorization for REDEMPLO (plozasiran).
• The drug is the first siRNA medicine authorized in the EU to treat adult patients with familial chylomicronemia syndrome (FCS).
• Clinical data from the Phase 3 PALISADE study showed a median 80% reduction in triglycerides among patients receiving the 25 mg dose.

Arrowhead Pharmaceuticals (NASDAQ:ARWR) announced today that the European Commission has granted marketing authorization for REDEMPLO (plozasiran) as an adjunct to diet for treating adults with familial chylomicronemia syndrome (FCS).

This authorization marks the first time a siRNA medicine has been approved for FCS patients, regardless of whether their condition is confirmed by clinical criteria or genetic testing.

"We are pleased to have received EC approval for REDEMPLO as a new treatment option for people living with genetically or clinically confirmed FCS," stated Arrowhead Pharmaceuticals President and CEO Christopher Anzalone.

REDEMPLO utilizes the company’s proprietary Targeted RNAi Molecule (TRiM) platform to suppress the production of apolipoprotein C-III (APOC3), a protein in the liver that regulates triglyceride levels.

Following the announcement, the Arrowhead Pharmaceuticals share price was up 1.5% at $22.84.

The approval is backed by the Phase 3 PALISADE study, where combined doses of 25 mg and 50 mg plozasiran were shown to lower the incidence of acute pancreatitis by 83% compared to a placebo group.

The company is currently engaging with national health authorities across the European Union to initiate the commercial rollout of this new therapeutic option for patients struggling with the severe, rare disease.