The cholesterol-lowering effect of Sanofi and Regeneron Pharmaceuticals Inc.’s Praluent is significant, U.S. regulators said, while questioning whether the companies should have to prove the drugs cut the risk of heart attack and death before they’re used broadly.
High cholesterol is linked to heart disease, the No. 1 killer of Americans, and drugs that lower bad cholesterol are generally assumed to be good for the heart. Yet, Food and Drug Administration staff will ask outside advisers to consider whether, without a proven link between the drugs and lower heart deaths, cutting bad cholesterol levels is enough to approve the drug in certain patients, according to a report released Friday.
The medicine “significantly” lowered LDL, or low-density lipoprotein, cholesterol and was well tolerated by patients, FDA staff wrote.
The report comes ahead of a June 9 meeting of FDA advisers to consider the drug, which falls in a new class of therapies known as PCSK9 inhibitors. Agency advisers will consider another treatment of the same type from Amgen Inc. on June 10.
The possibility that LDL reduction isn’t always a surrogate for decreased risk of heart disease is “particularly relevant” now that statins are the go-to cholesterol treatment and have proven a heart benefit, FDA staff said in the report.
Regeneron shares rose less than 1 percent to $519.07 at 9:34 in New York. Sanofi fell 1.9 percent to 89.41 euros. Amgen gained less than 1 percent to $158.90.
In addition, FDA staff wrote that trials to measure a drug’s effect on the heart “is no longer considered the infeasible endeavor that it was when our advisory committee last discussed issues related to the pre-approval assessment of lipid-altering drugs approximately 25 years ago.”
Sanofi and Regeneron are seeking to sell Praluent to patients that aren’t able to control their cholesterol on statins alone or can’t tolerate them. The FDA staff also questioned whether calling patients statin intolerant in labeling for Praluent will be misleading and encourage patients to prematurely abandon statins.
Praluent and Amgen’s Repatha cut bad cholesterol levels by more than 60 percent in studies published in March in the New England Journal of Medicine. Both are attempting to show lower cholesterol levels will have a benefit on heart health as well in large clinical trials that will be completed in 2017.
Praluent, also known as alirocumab, is expected to be the first PCSK9 drug for sale in the U.S. The FDA is scheduled to decide whether to approve it by July 24, followed by a decision on Amgen’s treatment by Aug. 27. Praluent may generate $1.9 billion in sales for Sanofi in 2020, compared with $2.5 billion for Repatha, or evolocumab, analysts estimate.
The injections are meant to help difficult-to-treat patients.
Statins such as Pfizer Inc.’s Lipitor and Merck & Co.’s Zocor are the go-to treatment for high cholesterol, with one in four Americans at least 40 years old taking them, according to the National Center for Health Statistics. Yet about 15 percent of people on statins can’t tolerate them well because of muscle pain and weakness, according to an article in Circulation, an American Heart Association journal.