FDA nod for Evkeeza, as add-on therapy for HoFH

The US Food and Drug Administration has approved Evkeeza (evinacumab-dgnb) injection as an add-on treatment for patients aged 12 years and older with homozygous familial hypercholesterolemia (HoFH), a genetic condition that causes severely high cholesterol.

The FDA granted approval of Evkeeza to Regeneron Pharmaceuticals (Nasdaq: REGN), whose president and chief scientific officer, Dr George Yancopoulos, said: "Evkeeza is the first FDA-approved ANGPTL3 inhibitor and the latest example of the promise of Regeneron's development approach that harnesses genetic insights and pioneering technology to deliver new treatment options for patients who need them."

Patients with HoFH can develop premature cardiovascular disease, including heart attack and heart disease, when they are teenagers or in their 20s, and many do not improve with other cholesterol-lowering drugs. Without aggressive treatment, patients may die before age 30.