Praluent has received approval from the Food and Drug Administration (FDA), clearing the way for the use of the cholesterol-lowering drug to be utilized by patients. However, some observers are questioning the significant cost of the drug.
Food and Drug Administration regulators approved the drug for people with hereditary conditions leading to high cholesterol as well as patients suffering from cardiovascular disease.
Praluent has now been approved in the United States for those with heterozygous familial hypercholesterolemia (HeFH), the most common hereditary condition driving high cholesterol. Patients with clinical atherosclerotic cardiovascular disease, including stroke and heart attack victims, may also soon be able to receive the drug.
Statins are a class of drug currently used to lower cholesterol levels. European regulators have recommended Praluent for nearly all patients who have not responded to standard statin treatment plans. Final approval from the European Commission could come in September 2015. That body recently approved Repatha, a rival drug to Praluent.
Pharmacies are stating they will require approval before paying for the drug.
"We will try to avoid situations in which a patient has not had a good trial of a statin medication or situations where patients appear to be intolerant but there is no biochemical evidence of problems with liver or muscle enzymes," Troyen Brennan, chief medical officer for pharmaceutical giant CVS, said.
Praluent is administered by injection every two weeks, while Repatha is given every two or four weeks, depending on dosage. This antibody targets a protein called PCSK9, encouraging receptors in the lever to cleanse additional LDL (bad) cholesterol from the bloodstream.
A series of five scientific studies were carried out, in order to study the safety and efficacy of the drug. Nearly 2,500 patients were examined during the course of the research. Those subjects provided with the drug saw their LDL levels drop between 36 and 59 percent.
Regeneron, developers of Praluent, said their drug would sell wholesale for $1,120 for two doses, lasting a total of 28 days. This price is the same for both the 75 milligram (mg) and 150 mg doses of the vaccine. Over the course of a year, the drug would cost patients $14,560.
"Praluent provides another treatment option for patients with HeFH or with known cardiovascular disease who have not been able to lower their LDL cholesterol enough on statins. The FDA strongly supports continued work to provide new and innovative options for the treatment and prevention of cardiovascular disease," said John Jenkins, director of the Office of New Drugs at the Center for Drug Evaluation and Research.
Photo: FDA | Flickr