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FDA Clears Arrowhead’s Redemplo for FCS, Marking the Biotech’s First Approval

The quarterly at-home siRNA sets up a U.S. launch this year against Ionis’s pricier Tryngolza.

Overview

  • Redemplo (plozasiran) won FDA approval as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome.
  • Phase 3 PALISADE data showed a median triglyceride reduction of about 80% versus 17% for placebo and a lower numerical rate of acute pancreatitis.
  • Patients can self-inject Redemplo subcutaneously once every three months at home.
  • Unlike Ionis’s Tryngolza, Redemplo’s label does not include a hypersensitivity warning, with common side effects reported as hyperglycemia, headache, nausea and injection site reactions.
  • Arrowhead said U.S. availability is expected by year-end and announced a $60,000 yearly list price, positioning the drug against Tryngolza’s $595,000 price while patent lawsuits between the companies proceed.