Date: 2015-01-09
Type of
information: Results
phase: 3
Announcement: results
Company: Sanofi (France) Regeneron Pharmaceuticals (USA - NY)
Product: alirocumab (SAR236553/REGN727)
Action
mechanism:
- monoclonal antibody/RNAi/PCSK9 inhibitor. Alirocumab is a subcutaneously administered, fully-human antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) in clinical development. By inhibiting PCSK9, a determinant of circulating LDL-cholesterol levels in the blood, REGN727 increases the number of free LDL receptors which can bind to circulating LDL and clear it from the bloodstream. Alirocumab was created using Regeneron's pioneering VelocImmune® technology and is being developed by Regeneron in collaboration with Sanofi.
Disease: hypercholesterolemia
Therapeutic
area: Cardiovascular diseases - Metabolic diseases
Country: ODYSSEY CHOICE I: Bulgaria,Canada, Hungary,Israel,Norway,Slovakia,UK,USA - ODYSSEY CHOICE II: Australia, Belgium, Canada, Denmark, Netherlands, New Zealand,Spain, USA
Trial
details:
- ODYSSEY CHOICE I evaluated the efficacy and safety of alirocumab in 803 patients with hypercholesterolemia at moderate to high cardiovascular (CV) risk. It compared alirocumab 300 mg every four weeks with placebo. More than two-thirds (68 percent) of patients also received statin therapy. (NCT01926782)
- ODYSSEY CHOICE II evaluated the efficacy and safety of alirocumab in 233 patients with hypercholesterolemia with high CV risk and/or a history of intolerance to two or more statins. It compared alirocumab 150 mg every four weeks with placebo. No patients received statin therapy.
- In both trials, alirocumab-treated patients who did not achieve their pre-specified LDL-C goals, or who did not achieve at least a 30 percent reduction in their LDL-C levels from baseline, were switched to receive alirocumab 150 mg every two weeks at 12 weeks. (NCT02023879)
Latest
news:
- • On January 9, 2015, Regeneron Pharmaceuticals and Sanofi announced that two new ODYSSEY trials, which are the first Phase 3 trials to assess alirocumab administered every four weeks, met their primary efficacy endpoints. The trials compared the reduction from baseline in low-density lipoprotein cholesterol (LDL-C, or "bad" cholesterol) at 24 weeks with alirocumab versus placebo in patients with hypercholesterolemia. ODYSSEY CHOICE I evaluated the efficacy and safety of alirocumab in 803 patients with hypercholesterolemia at moderate to high cardiovascular (CV) risk. ODYSSEY CHOICE II evaluated the efficacy and safety of alirocumab in 233 patients with hypercholesterolemia with high CV risk and/or a history of intolerance to two or more statins. The most common adverse events in the trials (occurring in at least 5 percent of alirocumab-treated patients) were injection site reactions, headache, upper respiratory tract infection, arthralgia, nausea, sinusitis, pain in extremity, and fatigue. Injection site reactions occurred more frequently in the alirocumab groups compared to placebo.
- In both trials, alirocumab-treated patients who did not achieve their pre-specified LDL-C goals, or who did not achieve at least a 30 percent reduction in their LDL-C levels from baseline, were switched to receive alirocumab 150 mg every two weeks at 12 weeks.
- Detailed data will be presented at future medical congresses. Alirocumab is currently under clinical development and its safety and efficacy have not been evaluated by any regulatory authority.
Is
general: Yes
