FDA approves heart protection claims for Amgen cholesterol drug

FILE PHOTO: An Amgen sign is seen at the company's office in South San Francisco, California October 21, 2013. REUTERS/Robert Galbraith

(Reuters) - Amgen Inc can now promote the ability of its potent but expensive cholesterol drug to reduce the risk of heart attacks and strokes, after U.S. health regulators approved adding those benefits to the medicine’s prescribing label, the company said on Friday.

Amgen has long seen this development as critical to clearing onerous hurdles to patient access and unlocking the value of the drug, Repatha, which has had anemic sales since its August 2015 approval despite its billion-dollar potential.

The injected biotech drug was approved on the basis of its ability to dramatically lower bad LDL cholesterol.

But health insurers and pharmacy benefit managers have made it extremely difficult for patients to get the medicine, even those whose dangerously high cholesterol met criteria for use in the original label approved by the Food and Drug Administration.

As many as 75 percent of patients prescribed the medicine have been denied coverage despite numerous appeals, severely holding back sales. Repatha sales, while gradually improving, were just $89 million in the third quarter.

A study released in March of more than 27,500 patients showed that Repatha cut the risk of heart attacks by 27 percent and stroke by 21 percent compared with a placebo in high-risk patients already on high doses of cholesterol-lowering statins such as Pfizer Inc’s Lipitor. In the second year of the study, the benefits were more pronounced, with a combined heart attack and stroke risk reduction of 33 percent.

But Amgen by law was unable to promote those benefits until the FDA approved adding those claims. The company has repeatedly said having the heart benefits added to the official label was necessary to get insurers to loosen their purse strings.

“With this approval, it’s now more important than ever that appropriate patients obtain access to Repatha in order to avoid preventable heart attacks and strokes,” Tony Hooper, Amgen’s head of global commercial operations, said in a statement.

“We will continue to work with payers to help ensure the patients who need Repatha the most are able to get this innovative medicine,” Hooper said.

Reporting by Bill Berkrot; Editing by David Gregorio