The Food and Drug Administration (FDA) approves the marketing of two new cholesterol-lowering drugs from Sanofi and Regeneron Pharmaceutical, and Amgen Inc.
According to the FDA Advisory Committee, which had evaluated the drugs, Sanofi’s alirocumab, and Amgen’s evolocumab; both, have the ability to block a substance called PCSK9. Based on studies, PCSK9 interferes with the livers’ function in removing cholesterol from the blood. With this ability to inhibit PCSK9, the new drugs can prove to be more effective than the much-older anti-cholesterol medication, statins.
Lifestyle diseases have become even more prevalent. Many people all over the world are afflicted with cardiovascular diseases – the world’s leading cause of mortality – including type 2 diabetes, atherosclerosis, and stroke. Obesity is another alarming global concern, now affecting even very young children. Meanwhile, smoking, alcohol, and drug addiction have further aggravated the general society’s health condition.
Low-density lipoprotein (LDL) cholesterol, which greatly contributes to cardiovascular affliction, has become the subject of worldwide concern. In the US, according to the Center for Disease Control and Prevention, 71 million adults are suffering from high LDL.
This necessitated treatment with cholesterol-lowering medications, with statins being the widely-available drug for the past 20 years.
With the advent of the new drugs from Sanofi and Regeneron Pharmaceutical, and Amgen Inc, some medical experts have expressed elation over the FDA approval. According to Dr. Steven Nissen, a heart doctor at the Cleveland Clinic, these new medications are far more effective than any other cholesterol-lowering drug.
But, there is a concern among the general public if the drugs have the capacity to lower cholesterol without any cardiovascular risk.
This is the same concern that the FDA Advisory Committee stated in its recommendation to the FDA. They have approved the new drugs, but only for patients who have abnormally high cholesterol levels, due to a genetic disorder known as familial hypercholesterolemia.
The panelists said that they wanted more data on potential side effects, including allergic reaction and diabetes, as shown by brief studies conducted by Sanofi.
With Amgen’s evolocumab, common side effects were nasopharyngitis, respiratory tract infections, and backache. There were also potential safety issues, including the possibility of pancreatitis, type 2 diabetes, and reactions in injection areas.