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Regeneron Pharma: Evkeeza SBLA Granted FDA Priority Review

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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