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# FDA Accepts Regeneron BLA for Priority Review
- URL: https://www.fdaweb.com/fda-accepts-regeneron-bla-for-priority-review/
- Published: 2020-08-12T12:00:00.000Z
- Updated: 2026-09-14T16:24:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147420

FDA will give priority review to a Regeneron Pharmaceuticals BLA for evinacumab as an adjunct to other lipid-lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH). The company [says](https://www.marketwatch.com/press-release/fda-accepts-evinacumab-biologics-license-application-for-priority-review-as-a-treatment-for-patients-with-hofh-an-ultra-rare-inherited-form-of-high-cholesterol-2020-08-12?tesla=y&ref=fdaweb.com) evinacumab is the first investigational medicine of its kind to show efficacy in patients with HoFH, including patients with little to no low-density lipoprotein receptor function, by binding to and blocking the function of angiopoietin-like 3\. FDA set 2/11/21 as the PDUFA target date for its decision.

The agency granted evinacumab breakthrough therapy designation in 2017 for treating hypercholesterolemia in patients with HoFH.

Regeneron says the BLA was supported by a pivotal Phase 3 trial evaluating the efficacy and safety of evinacumab in patients with HoFH.