Summary
Regeneron Pharmaceuticals, Inc. (REGN) filed an 8-K on March 16, 2015, to disclose important clinical trial data for its investigational drug, PRALUENT™ (alirocumab). The filing announces the presentation of positive efficacy and safety results from the ODYSSEY CHOICE I and CHOICE II trials at the American College of Cardiology's 64th Annual Scientific Sessions (ACC 15). These trials evaluated PRALUENT at two different monthly dosing regimens (150 mg and 300 mg) in patients with poorly controlled hypercholesterolemia. Furthermore, the report indicates that a pooled analysis of adverse events from a broader set of nine Phase 2 and Phase 3 trials of PRALUENT, across various doses and regimens, will also be presented at ACC 15. This comprehensive safety data is crucial for regulatory review and investor assessment of PRALUENT's potential market entry and therapeutic profile. The detailed presentations are furnished as exhibits to the filing, providing investors direct access to key clinical data.
Key Highlights
- 1Positive efficacy results from ODYSSEY CHOICE I and CHOICE II trials for PRALUENT™ (alirocumab) monthly dosing (150mg and 300mg) were presented at ACC 15.
- 2The presented data focuses on PRALUENT's effectiveness in patients with poorly controlled hypercholesterolemia.
- 3A pooled safety analysis from nine randomized, placebo-controlled Phase 2 and Phase 3 clinical trials of PRALUENT is also being presented at ACC 15.
- 4This pooled safety analysis covers multiple PRALUENT doses and regimens, providing a broader safety profile assessment.
- 5The detailed presentations, including efficacy and safety data, are furnished as exhibits (99.1 and 99.2) to the 8-K filing.
- 6The event date for these disclosures was March 13, 2015, with the filing on March 16, 2015.