Shots:
- The EC has approved Evkeeza (an angiopoietin-like 3 inhibitor), as an adjunct to diet & other lipid-lowering therapies, to treat children (6mos. to 5yrs.) with HoFH
- Approval was based on model-based analysis that predicted similar or greater LDL-C reductions with Evkeeza (15mg/kg, Q4W) in children (6mos. to 5yrs.) at 24wks. Data from compassionate use in 5 children (1-4yrs.) depicted meaningful LDL-C reduction, consistent with older pediatric patients (≥5yrs.)
- Evkeeza is approved for HoFH patients (≥12yrs.), with the indication extending to ages 5-11yrs. in Dec 2023. It is now reimbursed & available in the US, UK, Canada, Japan & several EU countries, with early access in 13 other regions incl. Austria & France
Ref: GlobeNewswire | Image: Ultragenyx
Related News:- Ultragenyx Receives an Extended Approval for Evkeeza by the EC for 5 Years or Older Children with Homozygous Familial Hypercholesterolemia (HoFH)
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