FDA eyes Amgen cholesterol drug

Federal health regulators said Monday that a highly anticipated experimental drug from Amgen Inc. significantly lowers bad cholesterol. But officials have questions about who should take the drug and whether to approve it based on currently available data.

The Food and Drug Administration posted its review of Amgen’s Repatha ahead of a public meeting to consider its approval. Repatha is part of a new class of injectable, cholesterol-low- ering drugs that work differently from older statin drugs. The new drugs are considered the first major advance in lowering bad, or LDL, cholesterol in more than 20 years, and analysts expect them to generate billions of dollars in sales.

But the prospect of approving pricey new injectable drugs for one of the most common medical conditions in America is already drawing concerns from health insurers, providers and pharmacy benefits managers.

More than 73 million U.S. adults, or nearly one-third, have high LDL cholesterol, according to the Centers for Disease Control and Prevention. Those patients have twice the risk of heart disease.

The FDA is considering which patients should receive a prescription for drugs like Repatha.

Amgen, based in Thousand Oaks, studied the drug in several different patient groups, including those already taking statins, those who cannot take statins because of side effects and patients with a rare genetic disorder that causes extremely high cholesterol levels.

On Wednesday the FDA will ask a panel of outside experts which patients are most likely to benefit from the drug, considering potential risks seen in studies, including higher rates of pancreatitis and kidney problems. The same panel of experts will review a similar drug from Sanofi on Tuesday.

Both drugs block a substance called PCSK9, which interferes with the liver’s ability to remove cholesterol from the blood.

Shares of Amgen fell 78 cents, or 0.5%, to $156.47 on Monday.