The CHMP agenda for this month (May 17-20) has been released, and it includes three notable items, EMPEROR-Reduced, DAPA-CKD, and vericiguat, as well as several other cardiometabolic-related entries. Below, FENIX provides highlights and insights from the respective news items.
A series of cardiometabolic-related news items have been observed: Adocia announced positive results from a BioChaperone Lispro trial using insulin sourced from Tonghua Dongbao; and the CHMP agenda for this month’s meeting (January 25-29, 2021) has been released, and it includes one notable item: EMPEROR-Reduced is on the CHMP agenda but not believed to be up for an opinion. Below, FENIX provides highlights and insights from the respective news items.
Full results from the EMPEROR-Reduced HF CVOT were presented at the 2020 virtual ESC conference (view BI/Lilly press release) and published in the NEJM (view publication). Results demonstrated a 25% RRR in the primary composite endpoint (hospitalization for heart failure or CV death), which is consistent with the 26% RRR observed in AZ’s DAPA-HF. Below, FENIX provides thoughts on the EMPEROR-Reduced results in the context of DAPA-HF and the evolving HF landscape.
Lilly (press release; slides), AstraZeneca (press release; slides), and Lexicon (press release; slides link unavailable) hosted their respective earnings calls. Importantly, BI/Lilly announced positive topline results from the EMPEROR-Reduced outcomes trial in HFrEF patients with and without T2DM, AZ discontinued its small molecule GLP-1RA (MEDI7219), and Lexicon is restructuring its business to shift focus toward R&D. Below, FENIX provides insights into the EMPEROR-Reduced results in the context of the evolving SGLT2i HF market as well as thoughts on how Lexicon’s restructuring could be an indicator for the sotagliflozin CVOT results.