Regeneron/Sanofi’s PSCK9 Inhibitor Might Need Two-Week Dosing Schedule
This article was originally published in Pharmaceutical Approvals Monthly
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...
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.
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.
The news that the Biden Administration is considering asking Robert Califf to return as Commissioner of the US FDA is the latest twist in a most unusual transition process at the agency. But one message seems abundantly clear: the White House is perfectly happy with FDA as it is.