WASHINGTON, June 9 (UPI) -- A new group of injectable drugs that dramatically lower cholesterol is being considered for approval by the U.S. Food and Drug Administration, potentially offering a viable treatment for people who cannot take statins.
If approved, the new drugs would help people susceptible to the side effects of statins, however they could cost patients around $10,000 per year to take, giving some pause on whether a drug of that expense should be made available so quickly.
The two drugs, Sanofi's alirocumab and Amgen's evolocumab, interfere with an enzyme in the liver called PSCK9 that interferes with the organ's ability to remove low density lipoprotein cholesterol, or LDL, out of the blood. By blocking the enzyme and lowering LDL, this significantly lowers the chances for it to build up on artery walls, causing heart disease or blockages.
Statins, used for people with high cholesterol since their approval in 1986, reduce LDL by 30 percent to 40 percent, while PCSK9 inhibitors lower it 40 percent to 60 percent, Daniel Rader, a professor at the Perelman School of Medicine at the University of Pennsylvania who also advised Sanofi while the company developed the drug, told USA Today.
"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. "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."
Despite statin drugs being successful for many patients, they do not work for some patients, and for between 5 and 15 percent of patients who use the drug they also carry risks of muscle breakdown and weakness, causing discomfort and pain.
The FDA is considering the drugs' potential side effects, and whether to limit approval to high-risk patients, according to a committee brief on clinical studies of the drugs.
