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Regeneron and Sanofi Present Positive Phase 3 Investigational Data for Praluent (alirocumab) Injection in Patients Undergoing LDL Apheresis Therapy at ESC Congress 2016

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Additional Relevant Details The trial demonstrated that adding Praluent to existing therapy reduced LDL cholesterol by approximately 50 percent from baseline (compared to 2 percent increase for placebo). Praluent significantly reduced the need for apheresis treatment by 75 percent compared to placebo (p less than 0.0001), the primary endpoint of the study. Results will be presented today at a Hot Line session at the ESC Congress 2016 in Rome, Italy.

Other key results from ODYSSEY ESCAPE, which will be concurrently published in the European Heart Journal, include: Š Ninety-three percent of patients treated with Praluent experienced at least a 50 percent reduction in their apheresis procedures (p greater than 0.0001). Š Throughout the trial, patients treated with Praluent experienced significant reductions in their LDL cholesterol starting at week 6 (55 percent greater reduction compared to placebo), and lasting until the trial ended, at week 18 (46 percent greater reduction compared to placebo) (p less than 0.0001). Š A similar proportion of patients experienced adverse events (AEs) in both the Praluent and placebo groups (76 percent both groups). The most common AEs (occurring in at least 5 percent of the Praluent group) were: fatigue (15 percent Praluent; 10 percent placebo), nasopharyngitis (10 percent Praluent; 10 percent placebo), diarrhea (10 percent Praluent; 0 percent placebo), myalgia (10 percent Praluent; 5 percent placebo), upper respiratory infection (7 percent Praluent; 19 percent placebo), headache (7 percent Praluent; 5 percent placebo), arthralgia (7 percent Praluent; 10 percent placebo), and back pain (5 percent Praluent; 10 percent placebo).  
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Catalyst Date
Occurred on:
Aug 29, 2016
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Related Keywords Praluent, Alirocumab, Ldl Apheresis, Esc Congress 2016