Drug Label Extension

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FDA Approves Label Extension of REGN's Cholesterol Drug Evkeeza
ZACKS· 2025-09-29 13:30
Key Takeaways Regeneron gained FDA approval to expand Evkeeza use to children aged 1 to under 5 with HoFH.The label extension was supported by efficacy and safety data from six young HoFH patients.Evkeeza posted $72.1M in U.S. sales in H1 2025, with Ultragenyx handling ex-U.S. commercialization.Regeneron Pharmaceuticals, Inc. (REGN) announced that the FDA has approved a label extension of its cholesterol drug Evkeeza (evinacumab-dgnb).Evkeeza ANGPTL3 antibody has been approved as an adjunct to diet and exer ...