SANOFI*S PRALUENT APPROVED BY EUROPEAN COMMISSION FOR LDL CHOLESTEROL
@ French pharmaceutical major Sanofi and Regeneron Pharmaceuticals have announced the European Union drug regulator*s approval for Praluent (©).// The drug has good potential in the European market for bad cholesterol patients.// Praluent has been approved by the U.//S.// FDA two months back.//
@ Sanofi informed that the European Commission has approved Praluent for treatment of bad cholesterol for adult patients with hypercholesterolemia.// Sanofi and Regeneron informed that the PCSK9 inhibitor will be available in single 1 milliter (mL) injection (75 mg and 150 mg) dosage.//
@ Patients will be able to self administer the medicine as the pharmaceutical majors will launch the drug in a single dose pre filled pen.// ©High LDL level is a major risk factor for heart disease across the world.//
@The drug was approved by the European Commission after checking results of 10 pivotal Phase 3 ODYSSEY trial.// The clinical data for Praluent showed reduction in LDL cholesterol compared to placebo or ezetimibe regimen.// The trails conducted at independent labs met their primary endpoints.//
@ Sanofi added, **In the© placebo controlled trials, the average LDL cholesterol reductions from baseline at week 24 for the Praluent group ranged from 46 to 61 percent.// In the ezetimibe controlled trial with Praluent added to background statins, the average change in LDL cholesterol from baseline was 51 percent at week 24.//**