Sanofi/Regeneron’s PSCK9 Inhibitor Alirocumab Passes First Phase III Test
This article was originally published in The Pink Sheet Daily
Executive Summary
PCSK9 inhibitor alirocumab outperforms Merck’s Zetia as a monotherapy in first Phase III trial reported, a result that has relevance for the large population of statin-intolerant patients, according to the drug’s sponsors.
You may also be interested in...
Panel To Weigh Amarin’s Expanded Vascepa Use Given Clinical Outcome Concerns
FDA advisors will discuss Oct. 16 whether Vascepa’s effect on reducing triglycerides is enough to overcome concerns about this surrogate endpoint not panning out in other drug’s clinical outcomes trials.
The Medicines Co. Enters PCSK9 Race With Alnylam Deal
The Medicines Company and RNAi therapeutics company Alnylam have teamed up to develop a new drug targeting PCSK9 for the treatment of high cholesterol, but they are far behind the leaders in the pack and will have to differentiate their product from the others in the race.
Momentum Builds For PCSK9 Class, But Proof Of Safety Still Thin
Amgen’s Phase II program for its PCSK9 inhibitor AMG 145 impresses when it comes to lowering cholesterol. But the studies were only 12 weeks long and the bigger test for monoclonal antibodies like AMG 145 and Sanofi/Regeneron’s rival REGN727 is proof of longer-term safety in bigger trials.