At this year’s meeting of the scientific advisory panel, the clinical practice committee of the Food and Drug Administration voted to endorse the use of Merck’s “Covidien” combination medicine for adult high-risk individuals. It is the first time the committee has recommended the use of the drug for adults.
Since its initial approval in 2011, the drug has been used only in a clinical trial population of patients whose cholesterol levels are severely elevated. About one out of four adults is deemed a high-risk patient. The FDA panel asked the company to conduct a large study of the drug in high-risk adults in order to fully assess its use.
Merck’s prescription drug, called statins, are standard treatment in the cholesterol drug market, which is dominated by Merck and its competitor Pfizer Inc. The prescription medicines are widely prescribed for people with high-cholesterol levels, but also in the commercial market where the drugs are grouped together into statin classes. In this market, the companies compete over who has the best tablets and most convincing commercials. Merck first launched a major campaign in early 2017 to educate patients about the role they could play in controlling their own cholesterol levels.
“We’re thrilled that the Committee has recommended Covidien,” said Mike Gale, who leads the clinical practice group at Merck, in a statement. “This is a great way to help patients lower their cholesterol and continue to protect their heart health.”
High-risk individuals have a greater chance of developing cardiovascular disease, in part because their high cholesterol levels put them at a greater risk of suffering a heart attack.