Regeneron’s Evkeeza Receives the US FDA’s Approval to Treat Homozygous Familial Hypercholesterolemia in Younger Patients
Shots:
- The US FDA has approved label expansion to Evkeeza (evinacumab-dgnb) as an adj. to diet, exercise & other lipid-lowering therapies for the treatment of children (1 to <5yrs.) with homozygous familial hypercholesterolemia (HoFH)
- Approval was supported by efficacy & safety results in 6 children with HoFH (incl. PK data from 4) who participated in either the US expanded access program or an ex-US compassionate use program for Evkeeza
- Evkeeza, developed by Regeneron using VelocImmune tech, is a fully human monoclonal antibody that blocks ANGPTL3 to lower LDL-C, with Regeneron handling US distribution as well as development & partnering with Ultragenyx for global development & commercialization
Ref: Regeneron | Image: Regeneron | Press Release
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