FDA Approves PCSK9 Inhibitor

The US Food and Drug Administration on Friday approved the first cholesterol-lowering treatment in a new class of drugs known as proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors.

The agency gave the green light to

Alirocumab (Praluent/Sanofi-Regeneron)

for use in addition to diet and maximally tolerated statin therapy in adult patients with heterozygous familial hypercholesterolemia (HeFH) or patients with clinical atherosclerotic cardiovascular disease such as heart attacks or strokes, who require additional lowering of LDL cholesterol.

Cardiologists

have been eagerly awaiting these drugs.

In addition to Sanofi-Regeneron's Praluent, another PCSK9 inhibitor, Evolocumab (Repatha/Amgen), could soon hit the market. Evolocumab was approved in Europe July 21 and is scheduled for a Aug. 27 FDA ruling.

Both companies have developed monoclonal antibodies that block a protein called PCSK9 from interfering with the liver’s normal method of disposing of LDL. The drugs were developed after researchers noticed that people with a genetic mutation that resulted in their not having any PCSK9 also had low LDL cholesterol.

Manufacturers have been aggressively competing to get their drugs to market first. The total market for PCSK9 inhibitors has been estimated at $8 billion to $9 billion annually.

Pfizer also has a drug candidate in the pipeline, an agent known as bococizumab.

The anti-cholesterol drugs are expected to cost around $8,000 a year. Statins can cost as little as $12 a month.

The PCSK9 inhibitors will not be for all patients with high cholesterol, just those who cannot take statins, patients who take statins but still have high LDL levels, and patients with inherited hypercholesterolemia.

Eventually, if the price comes down dramatically, far more patients might take them. .