The basics:

• FDA approves Merck‘s Lipfendra for adults with hypercholesterolemia
• Lipfendra is first FDA-approved oral PCSK9 inhibitor
• Once-daily pill lowered LDL cholesterol by nearly 60% in late-stage trials
• Merck pricing drug at $315 for a 30-day supply

Rahway-based Merck has secured U.S. Food and Drug Administration approval for a once-daily pill designed to lower artery-clogging cholesterol.

Branded as Lipfendra, the drug works by blocking a liver protein that limits the body’s ability to clear LDL cholesterol from the blood.

As the first approved oral PCSK9 inhibitor for adults with hypercholesterolemia, Lipfendra gives patients a pill-based option in a drug class that has traditionally relied on injections.

Hypercholesterolemia can be caused by lifestyle and other health factors, but some people inherit a genetic form of the condition that causes dangerously high cholesterol levels from birth.

PCSK9 injectables from Amgen, Regeneron and Sanofi have been on the market for years. However, the Associated Press noted that patient access has been stymied by high prices, insurance restrictions and limited prescribing by doctors.

Merck’s 20-milligram pill can be used with other cholesterol-lowering therapies, including statins, the company said.

By blocking the protein involved in regulating LDL cholesterol, Lipfendra can help the liver to remove more cholesterol from the bloodstream, according to Merck. By contrast, statins work by targeting an enzyme that the liver uses to make cholesterol. But even at the highest doses, many patients may need additional help reducing their LDL cholesterol enough to meet medical guidelines.

‘A pivotal moment’

About 1 in 4 adults in the U.S. has high LDL cholesterol, the so-called “bad” cholesterol, according to the American Heart Association. That can lead to plaque buildup in the arteries which increases the risk of heart disease and stroke.

While an LDL level of 100 is considered fine for healthy people, doctors recommend lowering it to at least 70 once people develop high cholesterol or heart disease, and even lower for those at very high risk, the ADA says.

The FDA based its July 16 decision on two late-stage trials that showed the once-daily pill decreased LDL cholesterol by nearly 60% in patients with hypercholesterolemia.

According to BioPharma Dive, Lipfendra will cost $10.50 a day, or $315 for a 30-day supply.

The outlet noted the price represents a “meaningful discount” to the $500-$600 monthly cost of injectable PCSK9 drugs, as well as the $400 to $600 charged for a branded statin.

The pharma also plans to make Lipfendra available at a lower price through trumprx.gov, BioPharma Dive reported. Launched earlier this year by the White House, the website offers cash discounts on certain prescription drugs.

Merck Research Laboratories President Dean Yi said, “This is a pivotal moment as we bring the first U.S. FDA-approved oral PCSK9 inhibitor to adults with high LDL-C, offering patients an important new option. We’re proud of our work with regulators on this rigorous and efficient review process.”

An ongoing clinical trial is studying ⁠the effect of Lipfendra on cardiovascular morbidity and mortality, according to Merck.