Two new drugs that can dramatically lower cholesterol on Wednesday won endorsements from Food and Drug Administration advisers, a last step to full approval.
The two drugs must be injected, so they wouldn't be as easy to take as a pill. And they are in a class of biotech drugs called monoclonal antibodies, so they are likely to be very pricey — perhaps $10,000 or even more a year. The panel recommends only certain people be prescribed the drugs, so they are not for everybody.
But studies show they can reduce bad cholesterol to extremely low levels, without the side-effects suffered by some people who take statins. Heart experts have been very excited about them.
"These drugs lower bad cholesterol more than any drugs we've ever had in history," Dr. Steven Nissen, a cardiologist at the Cleveland Clinic, told NBC News.
"These drugs lower bad cholesterol more than any drugs we've ever had in history."
The advisory panel recommend that the drugs be used for only a few people – those with an inherited form of high cholesterol called familial hypercholesterolemia; those who cannot tolerate stains and those who can’t get their cholesterol down low enough with other drugs.
One big question remains — while the drugs lower cholesterol, it's not been shown whether they reduce the risk of heart disease and stroke the way statins do.
The FDA usually follows the advice of its panels, but not always.
Statins, with brand names such as Lipitor, Mevacor, Crestor and Zocor — are extremely popular. They're prescribed to about a 15 percent of U.S. adults and range in cost from about $11 a month for the cheapest generic version to $200 for a pricey name-brand.
But they have side-effects, including a rare type of muscle breakdown and weakness that affects somewhere between 5 and 15 percent of patients who take them, depending on who's doing the estimating.
The new drugs — Sanofi and Regeneron's alirocumab, to be sold under the brand name Praluent, and Amgen's evolocumab or Repatha — work in a completely different way from statins. They interfere with an enzyme on liver cells called PCSK9.
When people have too much PCSK9, it seems to interfere with the liver's ability to pull low density lipoprotein, the LDL or bad cholesterol, out of the blood. The new drugs are made of lab-engineered antibodies that interfere with PCSK9 and allow the liver to do its LDL-regulating job better.
“We look forward to continuing to work with the FDA as they complete their review of the Biologics License Application for Repatha (evolocumab), in hopes of bringing this important new medicine to patients with high cholesterol,” Amgen said in a statement.
