Alirocumab (Praluent/Sanofi, Regeneron) is a PCSK9 inhibitor used to reduce LDL levels in people with bad cholesterol and cardiovascular problems. It was the first cholesterol-lowering treatment approved in the PCSK9 class by the US Food and Drug Administration (FDA) in July 2015. Jay Edelberg, MD, PhD, vice president of Strategic Development & Launch Unit at Sanofi, sat down with MD Magazine at the 66th Scientific Session of the American College of Cardiology (ACC 2017) in Washington, District of Columbia to discuss new data from the phase 3 ODYSSEY clinical trial.
“The results demonstrated that genetics really teach us a lot,” Edelberg said. Alirocumab injections provided robust LDL reductions and the majority of the patients in the trial got to their treatment goal with just the 75 mg dose. Edelberg continued by explaining that even 60% of patients with familial hypercholesterolemia (FH), which is the highest form of LDL disruption, were able to get to their pre-defined goal with the 75 mg dose. Even more patients achieved their treatment goal with the 150 mg dose.
This phase 3 program, which is the largest of its kind in the lipid-lowering space to date, revealed positive numbers with the use of alirocumab.