FDA Gives Nod To New Cholesterol Lowering Drugs Praluent, Repatha

FDA, the US regulatory board, has approved new and more effective anti-cholesterol medications. The drugs are Sanofi and Regeneron’s alirocumab (Praluent) and  Amgen’s evolocumab (Repatha).

Regulatory committee panels had voted 11-4 to recommend approval for Repatha, although some panel members voiced concerns that Amgen relied primarily on studies lasting only 12 weeks.

The panels voted 15-0 for recommending approval of Repatha, but only for use in a rare subset of familial hypercholesterolemia, which is a genetic disease resulting in very high cholesterol levels. The subset, homozygous familial hypercholesterolemia, is estimated to affect one in 1 million people.

$23 Billion Per Year?

Ed Silverman, writing in the Wall Street Journal’s Pharmalot blog, says the medicines can be expected to come with a price tag of $7,000 to $12,000 per patient per year. They could cost the US health system as much as $23 billion a year. “These injectable drugs are already viewed by payers as potential budget busters along the lines of treatments for hepatitis C and some cancers,” Silverman said.

Repatha and Alirocumab’s working mechanism is different than cholesterol-lowering medication currently on the market. It acts by blocking a particular gene in the liver called PCSK9, causing LDL-cholesterol (bad cholesterol) to drop.

Most importantly, the drop in cholesterol levels, which have been shown to be as much as 65 percent, have had little to no side effects in clinical trials. Side effects, if any, experienced by patients were similar to those seen in a placebo.

Trials have not yet ruled out all potential side-effects that the drugs may have. In some of the clinical trials, patients reported neurocognitive effects such as attention deficits and confusion.

Trials and studies are still being done on heart disease reduction and life expectancy increases. Results be available in 2017.

These PCSK9 blockers are not administered as a pill, but come in self-injectable form, taken monthly or bi-monthly, dependent on treatment plan and formulation.

The study on alirocumab, published in the New England Journal of Medicine, uncovered very good results, with even patients already using statins experiencing blood cholesterol levels drop further. The clinical trial on evolocumab, also published in the New England Journal of Medicine, showed that the drug lowered LDL cholesterol levels by 61 percent, from a median of 120 mg per deciliter to 48 mg per deciliter.