U.S. experts urge approval of second cholesterol drug
U.S. experts urged regulators Wednesday to approve a second new anti-cholesterol drug, a day after recommending they bring to market the first in a new class of medications to lower the risk of heart attack.
Published Thursday, June 11, 2015 7:10AM EDT
GAITHERSBURG, UNITED STATES - U.S. experts urged regulators Wednesday to approve a second new anti-cholesterol drug, a day after recommending they bring to market the first in a new class of medications to lower the risk of heart attack.
The advisory panel to the U.S. Food and Drug Administration voted 11-4 that the benefits of Amgen's drug evolocumab outweighed the risks, and was unanimous in its decision that the drug should be approved.
The same group voted 13-3 in favor of alirocumab by Sanofi and Regeneron Pharmaceuticals on Tuesday.
The FDA does not have to follow the advice of its advisory panel, though it often does so.
Both drugs block a gene in the liver, known as PCSK9, which results in plummeting levels of the bad kind of cholesterol, known as LDL.
They do not come in pill form but are injected every two weeks or every month, depending on the formulation.
The new medications work differently than the popular anti-cholesterol drugs known as statins that are currently in wide use, with popular brands including Lipitor, Pravachol, Crestor and Zocor.
Experts say the new drugs lead to dramatic drops in LDL cholesterol, as much as 65 per cent, and that side effects are similar to those seen with a placebo.
While data on whether the drugs actually lead to longer lives or less heart disease will not be available until 2017, pharmaceutical companies say the drugs could help between eight and 11 million Americans.
Those eligible could include people who suffer from high cholesterol but cannot take statins due to their side effects, people who have diabetes or other high-risk factors, or who simply cannot get their cholesterol low enough with diet, exercise and statin therapy.
Cholesterol leads to plaque buildup in the arteries, and can cause heart attack and stroke. Heart disease is the number one killer of Americans.
After Tuesday's meeting Elias Zerhouni, Sanofi's global research and development president, said the company was "pleased with the committee's recommendation to approve Praluent," the brand name of alirocumab.
"Our clinical trial program focused on patients with high unmet need in which Praluent delivered significant reductions in LDL-C of top of statins and other lipid-lowering therapies."
According to the results of a clinical trial on evolocumab, or Repatha, which was presented in March, the drug lowered the risk of heart attack and cardiac death by 53 per cent.
Analysts say the drugs, if approved, could generate more than $2.5 billion annually for each of the pharmaceutical companies that make them.