The FDA (US Food and Drug Administration) on 24 July 2015 approved the first in new class of drugs for the treatment of high cholesterol. Praluent (alirocumab) is an injectable drug under the class of PCSK9 (proprotein convertase subtilisin kexin type 9) inhibitors.
The drug is only approved for patients with HeFH (heterozygous familial hypercholesterolemia), a genetic disease that increases LDL aka bad cholesterol and in patients who have a previous history of cardiovascular disease such as heart attacks, strokes and other related conditions. The drug is further approved for use in conjunction to diet and maximally tolerated statin therapy. Statins are currently the go to treatment to reduce bad cholesterol.
Praluent (antibody) acts by targeting the PCSK9 inhibitor which reduces the number of receptors on liver that removes the bad cholesterol (LDL) from blood. Praluent works by blocking the actions of PCSK9, as a result of which there are more receptors available to remove the bad cholesterol thereby lowering its levels in the body.
Five placebo-controlled clinical trials studied the efficacy and safety of Praluent in 2,476 patients with HeFH or those that were associated with heart diseases taking tolerated doses of statins with or without other lipid modifying therapies. It was found that Praluent reduced LDL by 36 to 59 percent as compared to placebo.
Further trials on adding Praluent to statins is ongoing and results are not expected until 2017. Some of the side effects of Praluent as told by the FDA are itching, swelling, pain, or bruising where injection is given, nasopharyngitis, and flu. In case of serious side effects immediate medical help is advised. The put offs of this drug includes its route of administration (injectable) and its high cost. Analysts predict that the drug can become a huge seller.
In India, the number one cause of death is attributed to heart diseases, both in rural and urban areas. Out of which 25% is in the age group of 25-69 years. Globally one third of ischaemic heart disease is attributed to high cholesterol. Considering these numbers the new drug can bring hope to patients who suffer from high cholesterol even though it will be a while before the drug is marketed in India. The drug is currently marketed by Sanofi based in Bridgewater, New Jersey, and Regeneron Pharmaceuticals Inc., based in Tarrytown, New York.