Drug Approvals / Large Molecule

Sanofi-Regeneron cholesterol drug wins expanded approval

Apr 29, 2019

The U.S. FDA approved Regeneron Pharmaceuticals' cholesterol drug, Praluent, as a treatment to cut the risk of heart attacks, stroke and other major cardiovascular events.

The injectable biologic, developed along with Sanofi, can now be prescribed to reduce the overall risk of major adverse cardiovascular events (MACE).

Praluent was first approved in the U.S. in 2015 for use as an add-on treatment to statin therapy in adults with heterozygous familial hypercholesterolemia, a condition that causes cholesterol levels in blood to shoot up.

The drugmakers cut the list price of Praluent by 60 percent in February, to match the price of Amgen's Repatha, another treatment to cut the risk of heart attacks.

Read the press release.

Don't miss your Daily Dose.  Subscribe to our eNewsletter here!