The FDA advisers are scheduled for a meeting this week for discussing whether to grant the approval of a new class of cholesterol-lowering drugs that could be of assistance to individuals who are unable to take statins.
These new injectable drugs fall in a category of biotech drugs known as monoclonal antibodies indicating that they would be very expensive, probably $10,000 a year. The studies have made it evident that the drugs has the ability to lower bad cholesterol to tremendously low levels without having the side-effects that has been suffered by some individuals who receive statins.
Dr. Steven Nissen, a cardiologist at the Cleveland Clinic said, “These drugs lower bad cholesterol more than any drugs we’ve ever had in history. 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?”
The statins are sold under brand names like Lipitor, Mevacor, Crestor and Zocor and are highly popular amongst patients. Almost 15% of adults in the US are prescribed with statins ranging somewhere between $11 for the most inexpensive and generic version to $200 for an expensive well-known brand.
There are many side-effects to statins which includes an unusual type of muscle breakdown and weakness which affects 5% to 15% of the patients who are known to depend on them.
The FDA passed a regulation in 2012 for directing the labeling on stains that consisted of warnings regarding confusion and loss of memory, heightened blood sugar which lead to Type 2 diabetes as well as muscle weakness.
Whereas the new drugs alirocumab and evolocumab that has been manufactured by Sanofi and Amgen work much differently compared to statins. These drugs meddle with PCSK9, an enzyme on liver cells.
Dr. Elliott Antman, of Brigham and Women’s Hospital and Harvard Medical School, who is president of the American Heart Association said, “When PCSK9 levels are low or the function of PCSK9 is inhibited, you have more LDL receptors, and the LDL levels in the blood will drop. The goal is to have a lower LDL level in the blood.”
