U.S. regulators won’t require Amgen Inc. (AMGN), Sanofi (SAN), Pfizer Inc. (PFE) and other companies developing the next class of cardiovascular medicines to prove the therapies prevent heart attacks and death before they’re approved. The drugs, known as PCSK9 inhibitors, will only have to meet the U.S. Food and Drug Administration’s existing standards for clearance, including whether they cut cholesterol and reduce blood pressure or inflammation, said Eric Colman, a deputy director in the drug evaluation and research branch.
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