Amgen’s anti-cholesterol drug Repatha has been cleared by the US Food and Drug Administration a month after Sanofi/Regeneron’s Praluent won the race to become the first PCSK9 inhibitor approved in the country.

As with Praluent (alirocumab), doctors can now use Repatha (evolocumab) to treat high levels of cholesterol, in addition to diet and maximally-tolerated statin therapy, in adult patients with heterozygous familial hypercholesterolemia, homozygous familial hypercholesterolemia, or clinical atherosclerotic cardiovascular disease, such as heart attacks or strokes, when necessary.

Clinical trials have shown that PCSK9 inhibitors can slash levels of low-density lipoprotein, or bad cholesterol, by up to 77% in patients already taking statins, and analysts are largely expecting the top contenders in the class to rake in peak sales of around $2 billion-$3 billion, although uptake could dampened by pricing. 

According to media reports, Repatha will be priced similarly to Praluent at around $14,000 a year (wholesale), which, given that patients will be switching from cheap generics and taking the drug over a lifetime, could have quite a financial impact. 

However, the intense competition between the two drugs could also give health insurers leverage to drive down prices. “The back-to-back approvals for Praluent and Repatha should allow natural market competition to influence the immediate cost for the PCSK9 inhibitors," Steve Miller, chief medical officer at pharmacy benefit manager Express Scripts, said in an emailed statement to Reuters.

"And we plan to leverage this competition to achieve the greatest possible discounts for our clients and patients.”

Amgen 'sensitive' to pricing concerns

But Amgen says it is “sensitive” to cost concerns, and noted that it would work with payers and other purchasers “to provide innovative pricing programs linking the net price of Repatha to the expected LDL cholesterol reductions and anticipated appropriate patient utilisation”.

In the US around 11 million people have uncontrolled levels of cholesterol despite treatment with statins or other cholesterol-lowering therapies, putting them at a much higher risk of cardiovascular events.

Repatha was the first PCSK9 inhibitor to receive a regulatory approval anywhere in the world, following a green flag from the European Commission in July.