The FDA on Friday approved Sanofi’s and Regeneron’s Praluent, making it the first PCSK9 inhibitor to come to market in the US. It is part of a new touted class of cholesterol-lowering drugs. PCSK9 ...

The FDA approved Amgen’s PCSK9 inhibitor, Repatha, setting up a battle for market share with Sanofi’s and Regeneron’s Praluent in one of the most hyped new drug classes of 2015. PCSK9 inhibitors are ...

The Food and Drug Administration (FDA) has approved Repatha ... convertase subtilisin/kexin type 9 (PCSK9) inhibitor drug class that has been approved; in July 2015, Praluent (alirocumab; Sanofi ...

The FDA today approved alirocumab, the first in the much-anticipated class of anti-cholesterol drugs called PCSK9 inhibitors, which have both cardiologists and managed care plans awaiting their ...

Most people with high cholesterol don’t need PCSK9 inhibitors. The FDA has only approved alirocumab and evolocumab for people with genetic high cholesterol or serious heart disease including ...

Amgen announced that the Food and Drug Administration (FDA) has approved Repatha ... a proprotein convertase subtilisin kexin 9 (PCSK9) inhibitor, is already approved as an adjunct to diet ...

Two FDA-approved PCSK9 inhibitors, alirocumab and evolocumab, are monoclonal antibodies administered via subcutaneous injection. They have been shown to reduce LDL cholesterol by up to 60% and ...

Enlicitide, which could be the first oral medication that blocks the protein PCSK9, helped cut cholesterol levels in a pair ...

subcutaneous injection alternative to approved PCSK9 inhibitors. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of December 12, 2025. The FDA is not currently planning to ...