FDA approves a first-of-its-kind pill to cut cholesterol in high-risk patients
The FDA has approved Lipfendra, a new oral medication from Merck designed to lower cholesterol by blocking the PCSK9 protein. This pill offers a non-injectable alternative for high-risk patients who do not respond sufficiently to statins.
Why it matters
This approval provides a more accessible and potentially cheaper treatment option for patients with high cholesterol, addressing limitations of existing injectable therapies.
The Food and Drug Administration has approved a first-of-its-kind pill that can drastically reduce cholesterol in a way that's previously only been available with expensive, injectable drugs.
The drug from Merck was OK'd on Thursday for patients with artery-clogging cholesterol that persists even after taking statins, the standard medications for cutting heart attack risk. Merck will market its pill under the brand name Lipfendra.
It's the first noninjectable medication that works by blocking a liver protein called PCSK9. That protein limits the body's ability to clear cholesterol from the blood, and biotech injectables targeting it have been available from Amgen and other drugmakers for more than a decade. But patient access has been stymied for years by high prices, insurance restrictions and limited prescribing by doctors.
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