On Tuesday, a panel of federal health advisers recommended the U.S. F.D.A. on a 13-3 vote to approve a much-lauded cholesterol drug called Praluent.
The injectable drug is produced by Regeneron Pharmaceuticals and Sanofi, but despite the high hopes people have for it, more scientific data on its ability of reducing heart attacks is required.
As a result, the panel asked the Food and Drug Administration to request additional research before granting it final approval. Some panelists even recommended the FDA to grant the drug a partial approval. They said that Praluent should be used only on people with dramatically high cholesterol levels generated by a genetic disorder.
Those scientists argued that they needed more data to properly asses the safety of the drug before they could recommend it as safe for broader use.
“I personally fall on the side of having optimism, but I need to see the cardiovascular outcome study to know,”
said Philip Sanger, a researcher from Stanford University recommended the drug.
The members of the panel also suggested the FDA to gather more follow-up data on the drawbacks of the new drug. Some short-termed studies conducted by its producers showed that the new cure may lead to cognitive problems, diabetes and allergies.
The FDA is not legally bound to follow the panel’s guidance, but it often did. On Wednesday, the advisory panel is expected to revise another cholesterol drug, which is produced by Amgen.
During clinical trials, the new drugs have proven more efficient than statins with a higher rate of reducing cholesterol levels. They both work on a chemical dubbed PCSK9, which hinders the liver in its efforts to reduce blood cholesterol. If the new therapies get the FDA’s final approval, statins, which had been the standard cure for more than two decades, will be dropped.
Big pharmas also hope that PCSK9 drugs would be so successful that they would replace any other cholesterol medications and generate billions of dollars in sales. But the FDA panel’s decision curbed their optimism because of concerns that the new class of drugs may not be suitable to everybody.
In the United States alone, nearly on-third of adults were diagnosed with high LDL cholesterol levels, according to a CDC report. Doctors caution that a high LDL (or bad cholesterol) may trigger a series of health problems including doubling the risk of heart disease. In the U.S., heart disease is on the top list of causes of death by rate.
Image Source: Apple a Day