FDA grants priority review to evinacumab-dgnb for pediatric HoFH indication
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Regeneron announced the FDA has accepted for priority review the supplemental biologics license application for evinacumab-dgnb as adjunctive treatment for homozygous familial hypercholesterolemia in children aged 5 to 11 years.
The FDA target action date is March 30, 2023, according to a company press release.
As Healio previously reported, the FDA in February 2021 approved evinacumab-dgnb (Evkeeza), an angiopoietin-like 3 targeted therapy, as an adjunct to other lipid-lowering therapies for treatment of HoFH in patients aged 12 years or older.
The company reported that the application is supported by data from a three-part trial evaluating evinacumab-dgnb in 14 children aged 5 to 11 years with HoFH. Despite receiving other lipid-lowering therapies, participants had an average LDL level of 264 mg/dL.
The trial met its primary endpoint, according to the release. Evinacumab-dgnb plus other lipid-lowering therapies reduced LDL by an average of 48% at week 24 and the average absolute reduction from baseline was 132 mg/dL.
The observed safety profile of evinacumab-dgnb in children aged 5 to 11 years was generally consistent to those seen in patients aged 12 years and older, the company stated in the release.
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