The drug giant Merck on Thursday announced it had received FDA approval for a daily pill that can be an alternative to statins for treating high LDL levels, or so-called bad cholesterol. The new pill, Lipfendra, is a version of a drug called a PCSK9 inhibitor.
For decades the go-to therapy to treat high cholesterol levels has been statins, the most prescribed medication in the US. But statins come occasionally with side-effects like muscle aches and they sometimes don’t drop cholesterol levels enough to meet recommended levels.
Dr Puja Banka, associate vice-president for global clinical development at Merck and a pediatric cardiologist, said the development was important because statins are not doing enough to lower LDL levels to recommended levels.
“Seventy per cent of patients are not getting to their LDL goal,” she said.
The new pill, she said, would be taken “in conjunction” with statins, though in some cases could be taken alone. She said the side-effects of the newly approved drug appeared minimal in trials, with no muscle aches. Its side-effects, she said, “were like the placebo”.
Merck said the new drug should be ready within weeks.
Heart disease is the leading cause of death in the US and high LDL levels are known to cause atherosclerotic cardiovascular disease (ASCVD), or plaque buildup.
Acceptable LDL cholesterol levels vary according to a patient’s history and risk, but according to new guidelines issued in March the American College of Cardiology and the American Heart Association recommend that levels should always be below 100.
“To prevent a first heart attack or stroke, the LDL-C goal should be less than 100 mg/dL for those at borderline or intermediate risk and less than 70 mg/dL in those at high risk. For individuals with ASCVD who are at very high risk of ASCVD events, the LDL-C goal should be less than 55 mg/dL for secondary prevention of cardiac events,” according to the guidelines.
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The New York Times wrote that clinical trials show Merck’s new drug can bring LDL “down to 50 or 60 or even lower”.
Previously, this medication had to be taken as an injection. A pill is expected to make its use more widespread.
Merck says the drug’s list price will be $10.50 a day, or more than $300 a month, though it says it expects out-of-pocket costs to be lower for many patients.
