A new batch of cholesterol-lowering drugs could bring new hope to patients who can't take popular statins, or for those who don't feel their effects. Today, an FDA advisory committee recommended approval of Amgen's Repatha, reports AP, just one day after it gave the green light to a similar drug called Praluent from Sanofi and Regeneron. Both self-injected drugs are designed to lower LDL cholesterol (the "bad cholesterol") and belong to a class of drugs known as PCSK9 inhibitors, HealthDay reports. Early studies suggest they lower LDL more effectively than statins. The FDA will make its decision this summer, but is expected to follow the committee's advice, reports CNN, which calls the drugs "the most important new class of cholesterol-lowering medications since the first statin was approved in 1987." However, "definitive evidence" on whether they actually reduce heart attacks and deaths won't be out until 2017, after long-term trials, reports the New York Times.
While statins are proven to prevent heart attack and stroke, they don't work for everyone, and up to 25% of statin users battle side effects like muscle pain, which hasn't appeared in trials of PCSK9 inhibitors, notes CNN. However, some patients on PCSK9 inhibitors have reported being confused and unable to focus. "For all those patients unable to take statins, finally there might be an option that can change (their) outcomes," says a cardiologist not involved in the research. "We need to patiently wait for the next phase of trials to see whether the clinical outcomes are as promising as the initial studies suggest." The downside: Most estimates say the drugs could cost $10,000 per year, while statins cost a few hundred dollars per year.