The drug, named Praluent and produced jointly by pharmaceutical companies Sanofi and Regeneron, is being developed especially for those presenting genetic risk factors for cardiovascular diseases, by helping lower the amount of LDL cholesterol and preventing blood streams building up on fats.
In its written statement explaining the decision, the FDA said that it approved Praluent for patients who have already displayed cardiovascular disease symptoms – such as heart attacks, strokes or chest pain – and any who present high cholesterol levels due to genetic factors. It also noted that in can be used in addition to diets in adults who already take the highest amount of statins which their organism can tolerate.
However, the drug comes at a prohibitive price of $14,600, way higher than what most analysts were expecting. Sanofi and Regeneron have defended the high price tag by pointing out the benefits it brings and the fact that it could possibly save a lot of money for the health care industry by preventing heart attacks or other cardiovascular disease-related symptoms.
Health insurers and government programs typically get a significant discount on the list price. Despite this, analysts still expect the drug to be available mostly for higher tier insurance plans, with strict measures to be enacted to ensure that it won’t cause severe budget hits to patients.
Clinical trials have demonstrated that Praluent lowers the amount of bad cholesterol in the blood stream by at least 40 per cent. This applies also to patients already taking statins, the present go-to drugs for cardiovascular diseases. The drug is hailed as representing a significant advance in the fight against heart and blood vessel conditions.
But there is no actual data relating to how much it manages to prevent heart attacks or strokes, and the earliest observations are expected to be done by 2017, to offer enough time and a significant number of patients taking Praluent treatments for a relevant comparison with those who only use statins or other forms of cardiovascular disease prevention.
According to CDC statistics, heart diseases cause over 600,000 deaths in the U.S. each year, representing almost a quarter of total deaths and making it the most common death cause in the country. Listed risk causes are high LDL cholesterol, high blood pressure and smoking.
Image Source: hcahamilton.com