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FDA approves new Amgen cholesterol drug

Amgen’s new injectable cholesterol drug, Repatha.Amgen

Federal regulators on Thursday approved a new injectable drug that promises to sharply reduce levels of bad cholesterol in millions of people who need more than common statins but is also likely to spark another round of debate over the high prices of new medicines.

The drug, Repatha, developed by Amgen Inc., will be made in West Greenwich, R.I. It’s part of a new class of powerful but expensive medicines that block a protein called PCSK9 from degrading receptors that remove bad LDL cholesterol from the blood.

The first similar drug, approved by regulators last month, hit the market at a price of $14,600 per year. Insurers had hoped more competition would lower the cost of such treatments. But any immediate relief will be modest. Amgen said it plans to charge $14,100 per year for Repatha.

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More than 73 million Americans have high levels of LDL, or bad, cholesterol, according to the Centers for Disease Control and Prevention. About 15 percent, those who don’t respond to or are only partly helped by inexpensive and widely prescribed statins, are candidates for Repatha. But that is a huge market for Amgen, the largest US biotech by market value.

The Food and Drug Administration approved Repatha as a second-line therapy for patients with heart conditions who already take statins to prevent heart attacks and strokes.

“Repatha provides another treatment option in this new class of drugs for patients with [hereditary high cholesterol] or with known cardiovascular disease who have not been able to lower their LDL cholesterol enough with statins,” Dr. John Jenkins, head of the FDA’s Center for Drug Evaluation and Research, said.

While considered highly effective, the new PCSK9 inhibitors were immediately scrutinized by health insurers for their hefty price tags.

“The focus will be on how you deliver the best value and the best price for patients,” said Clare Krusing, spokeswoman for America’s Health Insurance Plans, an industry group. “But when these new medications across the board are bringing five- and six-figure price tags, that’s becoming the new norm. So we have to negotiate from a higher starting point.”

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Executive vice president Anthony C. Hooper said Amgen “is sensitive to the concerns of payers around cost, budget predictability, and paying for value.”

Repatha and the rival PCSK9 injectable called Praluent, made by Sanofi SA and Regeneron Pharmaceuticals Inc., may eventually face increased competition. But health insurers are expected to try to restrict the market for PCSK9 drugs to the highest-risk cardiovascular patients, said Peter Chang, principal scientific analyst at Informa PLC in San Diego.

“These drugs are a breakthrough,” Chang said. “They dramatically lower LDL cholesterol levels and have the potential to reduce cardiovascular events such as heart attacks and strokes even further for people who also take statins.”

Most cholesterol drug patients pay less than $250 a year because the statin market is dominated by low-cost generics, said Steve Miller, chief medical officer for Express Scripts, the largest pharmacy benefits manager, which negotiates pricing with drug companies on behalf of insurers and employers.

“These drugs represent an enormous step up to more than $10,000 a year,” said Miller, who added that drug makers hope to win approval for PCSK9 drugs as “first-line” treatments for primary prevention. “This will probably over time become the biggest class of drugs in history.”

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Even as second-line therapies, the new drugs could represent a big share of the market for all cholesterol drugs — projected to be as much as $24 billion in 2018 by the research firm IMS Health.

“We believe the PCSK9 class could be $5 billion to $10 billion worldwide long term, and Amgen could get around half the share,” said Michael J. Yee, at RBC Capital Markets.

Amgen’s drug will be produced at its plant in Rhode Island, where Amgen also makes Enbrel, a top-selling drug for rheumatoid arthritis, and Vectibix, for colorectal cancer.

The new drugs have been shown to lower bad cholesterol 54 to 77 percent. High levels of bad cholesterol increase the risk of heart disease.


Robert Weisman can be reached
at robert.weisman@globe.com. Follow him on Twitter @GlobeRobW.