Praluent, Sanofi’s LDL- lowering drug is hailed to have best results in its category and is currently awaiting approval by the FDA.
Praluent is still an experimental drug developed by Sanofi. FDA officials announced that during next week a meeting is set in place that will discuss the approval of the new drug.
Bad cholesterol as it is commonly known, or LDL is affecting a staggering number of 73 million U.S. citizens according to reports coming from the Centers for Disease Control and Prevention. High levels of LDL are doubling the chances of cardiac diseases.
Until recently, bad cholesterol was fought by the use of statin drugs which were introduced in the 1980s. Since then they have proved their efficiency repeatedly.
Praluent is part of a new generation of drugs that fight LDL. These are biotech drugs that are hailed to have even more efficient results than the statins in lowering the cholesterol levels in blood.
Initial studies conducted by Sanofi looked at the rates of LDL lowering as the patients participating were treated with statins or a combination of statins and the biotech drug.
For those taking statins in combination with Praluent, the LDL level fell by 46 to 60 percent. By comparing, the patients taking statins showcased a decrease in LDL levels of only 20 to 22 percent, depending on the dosage.
The FDA is still unsure whether Praluent should go on the market or not. Initially, the agency was willing to wait until 2017 when it is expected that additional trials will prove whether the biotech drug is capable of reducing the risk of heart attacks or the number of deaths due to LDL.
Now, the approval of Praluent depends on the opinion of an external expert panel which will deliver their findings and appreciations on Praluent on Tuesday.
In the same category, there is Repatha, a similar biotech drug developed by Amgen. Its review is due on Wednesday.
What Praluent and Repatha have in common is that they block the PCSK9 protein that prevents the liver from successfully removing low-density lipoprotein from the blood. Both drugs are injectable as well.
The main concerns of both patients and the medical community is that these new drugs, despite their hailed efficiency, will bring skyrocketing prices to the market. When looking at statins which come as cheap generics, the choice is not too hard to make.
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