Regeneron Pharma: Evkeeza SBLA Granted FDA Priority Review

(RTTNews) - Regeneron Pharmaceuticals, Inc. (REGN) said the FDA has accepted for Priority Review the supplemental Biologics License Application for Evkeeza as an adjunct to other lipid-lowering therapies to treat children aged 5 to 11 years with homozygous familial hypercholesterolemia. The FDA target action date is March 30, 2023. The sBLA is supported by data from a three-part trial.

The company noted that, if approved, Evkeeza would be the first and only treatment of its kind to help children as young as 5 years old control dangerously high levels of LDL cholesterol caused by homozygous familial hypercholesterolemia.

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