WASHINGTON (dpa-AFX) - 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.
For More Such Health News, visit rttnews.com.
Copyright(c) 2022 RTTNews.com. All Rights Reserved
Copyright RTT News/dpa-AFX
© 2022 AFX News
