Ultragenyx Receives an Extended Approval for Evkeeza by the EC for 5 Years or Older Children with Homozygous Familial Hypercholesterolemia (HoFH)
Shots:
- The extended approval came following the CHMP's positive recommendation for Evkeeza in Nov 2023 & was based on the P-III safety, tolerability, PK & efficacy evaluation of Evkeeza (15mg/kg, Q4W) in children aged 5-11yrs. with HoFH. The 1EP of the study includes the change in LDL-C at 24wks. & 2EPs include effect on other lipid parameters
- As per the results, children depicted a reduction in their LDL-C levels by 48% along with a significant reduction in other lipid parameters incl. levels of ApoB, non-HDL-C & total cholesterol
- Evkeeza, an ANGPTL3 inhibitor, received the initial approval by the EC as an adjunct to diet & other lipid-lowering therapies in adolescents & adults aged ≥12yrs. with HoFH in Jun 2021
Ref: Ultragenyx | Image: Ultragenyx
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Kritika is a content writer at PharmaShots. She is interested in covering recent innovations from the pharma & MedTech industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
