A new drug that could lower levels of "bad cholesterol" and reduce the risk of heart attacks and strokes was given the thumbs up by an FDA advisory committee.
An advisory committee at the Food and Drug Administration recommended today that a new cholesterol drug, Parluent, manufactured by Sanofi, be approved for trials. According to Philly.com, the new class of drug can fill in the treatment gaps for patients who are unable to treat their cholesterol levels with the current most popular class of drugs, statins.
The decision to approve the drug was made in a 13-3 vote. On Wednesday, the panel will decide the fate of a similar medication, called evolocumab (Repatha). Both of the medications belong to a new drug class called PCSK9 inhibitors.
PCSK9 is an enzyme that prevents the removal of LDL, or low-density-lipoprotein cholesterol from the body. By blocking this enzyme, early trials have shown that drug was extremely effective in lowering LDL levels in patients who saw no effect from statins treatment – in some cases by nearly 50 percent.
The drugs were also found to lower the risk of heart attack or death from heart disease. Though the results seem extremely positive, Dr. Seth Martin of Johns Hopkins University was quick to remind us that these were merely short-term trials, and the verdict is still out on whether PCSK9 inhibitors actually extend patients’ lives.
Experts won’t know how successful the drugs are at prolonging lifespans until large clinical trials are undertaken in 2017. While statins have long been the drug of choice for treating LDL cholesterol, the new class of drugs could be taken in tandem with statins to even more significantly lower LDL levels in some patients.
Statins can cause intolerable muscle pain in some patients, and in others they simply fail to lower LDL levels.
The new drugs haven’t been shown to cause muscle pain, but this does not mean that they are 100 percent safe for use. Dr. Martin has noted that there are certain potential “neurocognitive effects” of the drug, such as confusion or trouble focusing.
Before we can call game over bad cholesterol, we must remember that these trails were small and short-term. Many doctors or hopeful that the new treatment will be effective at a large scale, but we will have to wait and see until further trials are completed.
