Regeneron/Sanofi’s PSCK9 Inhibitor Might Need Two-Week Dosing Schedule
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Fully human antibody for hypercholesterolemia is set to enter Phase III next month, and while the firms aren’t discussing the protocol, recent data suggest that REGN727/SRA236553 may need dosing every two weeks, rather than the more convenient monthly schedule.
You may also be interested in...
Second-Quarter Earnings Updates, In Brief
In quarterly earnings calls, GlaxoSmithKline talks acquisition strategy while Regeneron is bullish on the sales prospects for its age-related macular degeneration drug Eylea and Sanofi highlights the recently initiated Phase III ODYSSEY program in hypercholesterolemia.
Branded Life After Lipitor: Pharma Targets Unmet Needs In Dyslipidemia
Statins represent a high standard of care for managing high blood cholesterol, bolstered by a strong evidence base, but new targets like PCSK9 and CETP are nevertheless stealing the spotlight nowadays. Whether new drugs, if they make it to market, will be used beyond narrow, targeted population segments is uncertain and will depend on results from large-scale outcomes studies showing significant efficacy and, importantly, reassurance of a solid safety profile.