Merck and the FDA announced the approval of enlicitide 20 mg as an add-on to diet and exercise to lower LDL in adults with hypercholesterolemia and those with heterozygous familial hypercholesterolemia.Enlicitide (Lipfendra), a novel macrocyclic peptide, is the first oral PCSK9 inhibitor FDA-approved to lower LDL, according to press releases from the company and the FDA.

The speedy clearance of Lipfendra is an important milestone for Merck and the result of a controversial voucher program put in place by former commissioner Marty Makary.

Merck and the FDA announced the approval of enlicitide 20 mg as an add-on to diet and exercise to lower LDL in adults with hypercholesterolemia and those with heterozygous…

With enlicitide, large LDL cholesterol reductions possible without a needle