Repatha, a cholesterol-reducing injectable drug manufactured by Amgen Inc., is set to be approved by Federal health advisers for use by patients with alarmingly high cholesterol levels. The FDA advisory panel voted in favor of Repatha in terms of its safety and effectiveness for certain patients, particularly those whose cholesterol problem is a result of hereditary conditions.
But based on the Food and Drug Administration’s review of the same drug on Tuesday, FDA experts opined the necessity of a long-term study to determine its real benefits. The FDA advisory panel made its endorsement of the drug notwithstanding pending results of a study establishing the probable relationship between intake of Repatha and lower rates of heart attack and death. Amgen earlier announced that the results of the study would not be ready until 2017.
Repatha, like its rival brand Praluent (produced by Sanofi and Regeneron Pharmaceuticals) is one of many brands of a group of drugs that lower cholesterol rates more than statins do by blocking PCSK9, a substance which restricts the liver from removing cholesterol from the blood. For more than 20 years, statins have been the standard prescription for patients suffering from high cholesterol levels. Since Repatha and Praluent are a combination of the new biotech drug and conventional statins, these drugs are expected to reduce low-density lipoprotein (LDL) or bad cholesterol by as much as 40 to 60 percent compared to pure statins who could only work by as much as 30-50 percent.
GlobalData, a medical analytics company group, estimates the PCSK9 class drugs to earn about $18 billion by 2023. This has raised concerns from health insurance companies and employers as more than 73 million Americans have high LDL cholesterol levels as reported by the Centers for Disease Control and Prevention; making this group twice as likely to suffer from heart diseases, America’s leading silent killer. Although none of the pharmaceutical companies mentioned the tentative price of their products, experts estimate the cost of these drugs at $10,000 or more a year. Statins would only cost hundreds of dollars per year.
Amgen has made it clear that “there is a critical need for additional treatment options for patients who are unable to control their high cholesterol despite currently available therapies.” Repatha is designed to be self-injected by the patient every two or four weeks, depending on the dose.”
Everything depends now on FDA as doctors’ prescription of the drugs will be governed by what FDA will put on the drugs’ label. FDA will carefully consider its advisory panels’ advice although it is not obliged to follow it.