Cholesterol-Lowering Drugs Being Considered by FDA, Meds Show Promise
A new class of cholesterol-lowering drugs is being considered by the Food and Drug Administration.
Unlike the old drug statins, the new ones are injectable but are very pricey, according to NBC News. However, studies have shown that the injectables are effective at lowering bad cholesterol with minimal side effects.
"The problem with statin drugs is that they can't get everybody's LDL down. Some people can't take them due to side effects, and a lot of people out there that we really want to get lower, we had no way to get them there until these drugs came along." said Dr. Steven Nissen, a Cleveland Clinic cardiologist.
Nissen also praised the new drugs because they "lower bad cholesterol more than any drugs we've ever had in history."
Some of the more common side effects of statins, as per Mayo Clinic, include: muscle pain, liver damage, rash, increased glucose levels that could develop to type 2 diabetes and memory problems, among others. However, it can reduce LDL or bad cholesterol by 30 percent to 50 percent, according to USA Today.
The new drugs from Sanofi and Amgen can block PCSK9, a substance that hinders the liver from removing cholesterol in the blood. According to ABC News, the new drugs could cost approximately $10,000 annually, more so than statins with only several hundred dollars a year. If the FDA were to approve the drugs for 10 million high-risk patients, the overall costs would soar to $100 billion a year.
PCSK9 can reduce bad cholesterol by 40 percent to 60 percent and can greatly help people who cannot endure the adverse effects of statins or those who can't lower their LDL levels with the old drugs alone.
Marquerite Echols McCoy, one of the trial participants, was hugely in favor of the new drugs. She told NBC that her legs cramped severely when she takes statins.
McCoy took three injections of the new drugs once a month.
"It's not painful. I do it myself. I have no side effects. It's an easier way for me to get rid of the bad cholesterol. No matter what exercise I did, my cholesterol was high. Now, my cholesterol is down in mid 70s and my HDL (high density lipoprotein or 'good' cholesterol) is where it's supposed to be. I'm having no cramps, and I feel great," she said.
The FDA will make its decision on Sanofi's drug on July 24 and Amgen's drug on August 27.