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Regeneron Reports the US FDA’s Acceptance of sBLA for Priority Review of Evkeeza (evinacumab) to Treat Homozygous Familial Hypercholesterolemia

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Regeneron Reports the US FDA’s Acceptance of sBLA for Priority Review of Evkeeza (evinacumab) to Treat Homozygous Familial Hypercholesterolemia

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  • The US FDA has accepted the sBLA for Priority Review of Evkeeza as an adjunct to other lipid-lowering therapies in children aged 5-11yrs. with HoFH. The US FDA’s decision is expected on March 30, 2023
  • The sBLA was based on the results from a three-part trial (parts A/B/C) evaluating Evkeeza. The trial met its 1EPs i.e., 48% reduction in LDL-C @24wk. by adding Evkeeza to other lipid-lowering therapies, patients treated with Evkeeza achieved 79% LDL-C reduction @24wk. with an absolute reduction in LDL-C from a baseline of 132mg/dL
  • The safety profile was consistent with that observed in adults & pediatric patients aged ≥12yrs. Evkeeza has been approved in the US, EU & the UK for patients aged ≥12yrs. with HoFH

Ref: Regeneron Image: Regeneron

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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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