The U.S. Food and Drug Administration approved a potent new cholesterol-lowering drug from Sanofi SA and Regeneron Pharmaceuticals Inc on Friday but limited its approved use to patients with a hereditary form of the condition and those with cardiovascular disease.
The FDA ruling came just hours after European regulators recommended approval for broader use of the drug in all patients with high cholesterol who are not able to bring it down despite taking maximal doses of statin. The Europeans also recommended it for patients who cannot tolerate statins.
The companies expect the drug to receive formal approval by the European Commision in late September. The Commission recently approved a rival drug made by Amgen Inc, Repatha.