FDA Considers Two New Cholesterol-Lowering Drugs: Advisory Committee Endorses Alirocumab By Sanofi And Regeneron Pharmaceuticals

An FDA advisory committee on Tuesday endorsed a new injectable drug called alirocumab by Sanofi and Regeneron Pharmaceuticals to treat high cholesterol. In clinical trials, the drug lowered the amount of harmful cholesterol in patients’ blood by about 60 percent. If the treatment is approved by the FDA, which is likely following the committee’s recommendation, it would be the first major breakthrough in treating high cholesterol and fighting heart disease in three decades.

But that progress comes at a price -- critics have complained of the potentially high cost for a new class of injectable cholesterol drugs that alirocumab represents. Drugs in this group may run between $7,000 to $12,000 a year, reports the Wall Street Journal. Statins, which have been available for decades to treat high cholesterol, only cost a few hundred dollars per year. Statins, however, don’t work in every patient and can cause side effects such as muscle weakness and confusion, reports NBC News.

The 13-3 vote is a good sign for pharmaceutical company Amgen, which will present data to the same committee on Wednesday on another injectable drug in the new class, called evolocumab. Both drugs affect a gene known as PCSK9 that regulates the amount of cholesterol in the blood. People with high cholesterol are about twice as likely to suffer from heart disease, which is the leading cause of death for both men and women in the U.S., according to the Centers for Disease Control and Prevention.

Patrick Gleason of Prime Therapeutics told the Wall Street Journal that as many as 2.3 million patients in the U.S. could receive the new drugs if they are approved. Together, the two candidates could run up annual charges as high as $23.3 billion for the healthcare system.

The FDA's Endocrinologic and Metabolic Drugs Advisory Committee heard Tuesday's argument for alirocumab, which will be sold as Praluent. The group will reconvene Wednesday to consider Amgen’s proposal for evolocumab, which will be sold as Repatha if approved. While the FDA’s final decision on both drugs may deviate from the opinion of its advisers, the agency nearly always follows the group’s recommendation.