FDA Considers Fate of Cholesterol Reducing Drugs
The United States Food and Drug Administration is currently considering the fate of a new group of injectable drugs that have already demonstrated their ability to dramatically reduce cholesterol, offering a potentially new viable treatment for people who cannot take statins.
If these new drugs are approved, they could potentially help patients that are highly susceptible to the side effects of statins, but they could cost patients around $10,000 a year to take, which gives the FDA pause on whether a drug that expensive should be made available so quickly.
The new group actually consists of two drugs, Sanofi's alirocumab and Amgen's evolocumab. These drugs are antagonistic to 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 this enzyme and lowering LDL, this greatly lowers the chances for it to build up on the walls of arteries, which causes heart disease or other blockages.
Traditionally, people with high cholesterol take statins, which have been shown to reduce LDL cholesterol by 30 to 40 percent. However, the new PCSK9 inhibitors have been shown to lower cholesterol levels by 40 to 60 percent, said Daniel Rader, a professor at the Perelman School of Medicine at the University of Pennsylvania who advised Sanofi during the drug's development.
"These drugs lower bad cholesterol more than any drugs we've ever had in history," says Dr. Steven Nissen, a cardiologist at the Cleveland Clinic. "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."
While statin drugs have been successful for many patients, they do come with potentially harmful side effects. For example, they carry risk of muscle breakdown and weakness and it is estimated that between 5 and 15 percent of patients can't take statins because of the discomfort and pain from the side effects.
Currently, the FDA is considering the drugs' potential side effects and whether or not to limit the approval of the drug to only high-risk patients.
It is estimated that approximately 73.5 million adults in the United States have high LDL Cholesterol while only one out of every three adults actually receive treatment to help get the condition under control. People with high cholesterol have twice the risk of suffering from heart disease which could lead to heart attacks and further medical complications.
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