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.

What is the New Pill?

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.

Statins block some of the liver’s production of cholesterol and are the cornerstone of treatment. But even at the highest doses, many people need additional help lowering their LDL, or bad, cholesterol enough to meet medical guidelines.

Effectiveness of the New Pill

Merck, which has headquarters in Rahway, New Jersey, won approval based on two studies in high-risk patients who added the company’s pill to their standard treatment, including statins. In one study of 3,000 patients, those taking Lipfendra saw their levels of LDL cholesterol drop more than 55% after six months. In a second study, patients averaged a reduction of 59% compared with patients who received a dummy pill.

That benefit dropped only slightly over a year, and side effects — including dizziness and diarrhea — were similar between those taking the pill or a placebo, researchers found. One caveat: The pill must be taken on an empty stomach.

Original reporting: WTVQ (Lexington) — read the source article.