See the DrugPatentWatch profile for Evkeeza
When did Evkeeza get FDA approval?
Evkeeza (evinacumab-dgnb) has FDA approval for lowering low-density lipoprotein cholesterol (LDL-C) in certain patients with homozygous familial hypercholesterolemia (HoFH) or mixed dyslipidemia/other specified high-risk lipid conditions, depending on the labeled population. [1]
What is Evkeeza, and what does it treat?
Evkeeza is an injectable monoclonal antibody (evinacumab-dgnb) used to reduce LDL-C. It’s prescribed for people who need additional LDL-C lowering beyond standard therapies, and it is used in specific FDA-labeled high-risk genetic or lipid disorders. [1]
Who can be prescribed Evkeeza under the label?
The FDA-approved indication is tied to defined patient groups (including people with HoFH and other labeled high-risk dyslipidemia categories). The exact eligibility depends on the product label’s specified conditions and use with (or despite) other lipid-lowering therapies. [1]
What does FDA approval mean for safety and effectiveness?
FDA approval means the therapy met FDA requirements for demonstrated effectiveness in lowering the targeted cholesterol measure(s) and an acceptable safety profile in the clinical data reviewed by the agency. The details come from the FDA-approved prescribing information. [1]
Where to check the most accurate approval details
For the exact approval date, current indications, dosing, warnings, and prescribing information updates, use the official FDA product label or the FDA’s drug listing linked in the reference below. [1]
Sources
[1] https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm