Amgen Inc.’s cholesterol-reducing drug will face questions from U.S. regulatory advisers on whether its significant cholesterol-lowering effects are enough to warrant approval without a proven link to lower heart-related deaths.
Food and Drug Administration staff are asking advisers in a report released Monday to weigh the issue when they discuss Amgen’s Repatha later this week. The regulators are raising the same question about Praluent, a competing drug by Sanofi and Regeneron Pharmaceuticals Inc.
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. The FDA doesn’t require drugmakers prove their treatments’ effect on cardiovascular health before gaining approval to sell them.
The drugs are part of a new class of treatments called PCSK9 inhibitors. They would be used in difficult-to-treat patients -- many who can’t get their cholesterol under control with widely used statins, such as Pfizer Inc.’s Lipitor, or who can’t tolerate statins.
Advisers to the FDA will meet Tuesday to discuss Sanofi and Regeneron’s Praluent, then turn to Amgen’s Repatha the following day. Both drugs are undergoing clinical trials on their effect on the heart, expected to be complete in 2017. An addendum to Monday’s FDA staff report said preliminary data from Amgen’s cardiovascular trial showed adverse side effects on the liver, though patients taking a placebo also experienced them -- a signal the FDA staff called “reassuring.”