Praluent (alirocumab) Injection Receives FDA Approval to Treat Children with Genetic Form of High Cholesterol - Seite 2

No new adverse reactions were identified in this trial, and the safety profile was consistent with the safety profile observed in adults with HeFH. Across Praluent trials in patients with primary hyperlipidemia (N=2,476), the most common adverse reactions (≥5%) more frequently observed with Praluent than placebo have been injection site reactions (7%), and influenza (6%) and diarrhea (5%).

“The approval of Praluent for the treatment of high cholesterol was a historic landmark achievement, as it was the first approved therapy targeting the genetically-validated PCSK9 target for heart disease,” said George D. Yancopoulos, M.D., Ph.D., Board co-Chair, President and Chief Scientific Officer at Regeneron, and a principal inventor of Praluent. “Praluent has made a meaningful impact in the treatment of adults with familial hypercholesterolemia, and we are proud that our innovation will now be able to help appropriate children with the heterozygous form of this disease manage their dangerously high levels of LDL-C.”

About the Praluent HeFH Pediatric Trial
The randomized multicenter Phase 3 trial consisted of a 24-week double-blind, placebo-controlled evaluating the efficacy and safety of Praluent in pediatric patients aged 8 to 17 years with HeFH (N=79). The primary endpoint was the percent change in LDL-C from baseline to week 24 in the Praluent and placebo treated patients. At baseline, patients were on a low-fat diet and being treated with background lipid-lowering therapy. In the trial, patients were randomized 2:1 to receive Praluent or placebo every 2 or 4 weeks. The Praluent dose was based on body weight.

About Praluent
Praluent inhibits the binding of PCSK9 to the LDL receptor and thereby increases the number of available LDL receptors on the surface of liver cells to clear LDL, which lowers LDL-C levels in the blood. Praluent was developed by Regeneron and Sanofi under a global collaboration agreement and invented by Regeneron using the company's proprietary VelocImmune technology that yields optimized fully-human monoclonal antibodies.

In the U.S., Praluent is currently indicated:

• to reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease
• as an adjunct to diet, alone or in combination with other low-density lipoprotein cholesterol (LDL-C) lowering therapies in adults with primary hyperlipidemia including HeFH to reduce LDL-C
• as an adjunct to other LDL-C-lowering therapies in adults with HoFH to reduce LDL-C
• along with diet and other LDL-C lowering treatments in children aged 8 years and older with HeFH to reduce LDL-C

In addition to the U.S., Praluent is approved in 60 countries, including the European Union, Japan, Canada, Switzerland and Brazil.