The U.S. Food and Drug Administration has approved the use of Praluent Injection, a cholesterol-reducing drug developed and marketed by Westchester-based Regeneron Pharmaceuticals Inc. and its French pharmaceutical partner Sanofi SA, as the first in a new class of drugs known as PCSK9 inhibitors.
The companies in a joint press release said Praluent is used as an adjunct to diet and standard cholesterol-reducing drugs called statins to additionally lower low-density lipoprotein (LDL) cholesterol in adults with heterozygous familial hypercholesterolemia ”“ an inherited form of high LDL cholesterol ”“ or clinical atherosclerotic cardiovascular disease, in which a build-up of plaque in the arteries can lead to reduced blood flow and heart attack, stroke and other diseases. Available in 75-milligram and 150-milligram doses, Praluent is self-administered by patients every two weeks.
The FDA approval was based on results in human subjects of the two companies”™ phase-three international Odyssey clinical trial program for Praluent. Its potential users in the U.S. include 8 million to 10 million patients with the inherited form of LDL cholesterol. Many patients do not achieve their physicians”™ recommended lower levels of high LDL, or bad, cholesterol despite dietary and lifestyle changes and use of standard cholesterol-reducing drugs, according to Praluent’s developers.
Dr. Leonard S. Schleifer, Regeneron president and CEO, in the announcement said Praluent “represents the culmination of more than a decade of tireless work to translate the genetic-based discovery of PCSK9 into an innovative medicine that brings meaningful value to patients.”
Regeneron and Sanofi set the newly marketed drug”™s wholesale list price in the U.S. at $40 per day for both 75-milligram and 150-milligram doses. The companies said the wholesale acquisition cost makes Praluent the lowest-priced patient-administered monoclonal antibody therapy on an annualized basis. Patients, insurers and health systems are expected to pay lower prices after discounts and rebates.
Regeneron and Sanofi said they will launch a comprehensive program of support, training and follow-up that includes assistance to uninsured or underinsured patients and free medicine for those eligible. For more information, call 1-844-PRALUENT.
