Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Regeneron Pharmaceuticals and Sanofi have said that their cholesterol-lowering drug, Praluent, met its primary endpoint in a phase 3 trial in patients undergoing LDL apheresis therapy.
Subscribe to our email newsletter
Praluent is a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor indicated as adjunct to diet and maximally tolerated statin therapy to treat adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic CVD, who require additional lowering of LDL cholesterol.
The phase 3 Odyssey Escape trial evaluated Praluent (alirocumab) Injection in patients with an inherited form of HeFH, whose cholesterol levels needed chronic, weekly or bi-weekly apheresis therapy.
Those who added Praluent to their existing treatment regimen reduced the frequency of their apheresis therapy by 75% compared to placebo (p<0.0001).
In addition, 63% of patients receiving Praluent no longer required apheresis compared to 0% for placebo.
The study involved 62 HeFH patients in the US and Germany. They were randomized to receive either 150 mg of Praluent subcutaneously every two weeks or placebo.
In the first six weeks patients remained on their established apheresis schedule. For the following 12 weeks, the frequency of apheresis was adjusted depending on their LDL-C response to treatment.
Regeneron VP of program direction Bill Sasiela said: "This is the first time a PCSK9 inhibitor has shown in a clinical study that it reduced the frequency of apheresis therapy, an invasive, difficult to access, time-consuming and expensive treatment for some of the most difficult-to-treat patients."
In July 2015, the US Food and Drug Administration approved Praluent to treat certain patients with high cholesterol.
Image: Sanofi Ampoules. Photo: courtesy of Sanofi.