Tag Archives: emperor-preserved

Jardiance Receives Breakthrough Therapy Designation for HFpEF; Metacrine Ph2a NASH Trial Completes Enrollment; Dario Signs Northeast Regional Employer

A series of cardiometabolic-related news items have been observed: BI/Lilly announced FDA granted Breakthrough Therapy Designation (BTD) to Jardiance for the treatment of HFpEF; Metacrine announced the Ph2a trial evaluating MET642 in 180 patients with NASH has completed enrollment; and Dario Health announced it was selected as the digital health provider for a Northeast regional employer. Below, FENIX provides highlights and insights for the respective news items.

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EMPEROR-Preserved Creates a Multitude of Complex Implications

Today, BI/Lilly presented positive full results from EMPEROR-Preserved, the heart failure outcomes trial (HFOT) for Jardiance in HFpEF. While the 21% relative risk reduction augmented the clinical utility of SGLT2i in HF, the lack of benefit in patients with a LVEF ≥60% was very surprising and opens up a multitude of implications and opportunities across CV medicine. Below, FENIX provides highlights, insights, and implications from EMPEROR-Preserved that are sure to make 2022 another dynamic year for the CV global landscape.

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Jardiance Positive HFpEF Topline Results (EMPEROR-Preserved)

BI/Lilly announced positive topline results from the Ph3 EMPEROR-Preserved trial, but it did not provide any information on the magnitude of effect. For context, EMPEROR-Preserved was evaluating 10mg empagliflozin in 5,988 adults with HFpEF, regardless of whether they have diabetes. Full results from EMPEROR-Preserved are scheduled to be presented as a Hot Line session at ESC 2021 on August 27. Below, FENIX provides a preliminary favors/disfavors analysis, including thoughts on how Lexicon’s sotagliflozin may still have residual value.

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