Tag Archives: LVEF

Kailera Files IPO; Diamyd Data Disappoints; Insilico and Lilly Partner for AI Drug Discovery; EMA Approves Bayer’s Kerendia for HFpEF; Gan & Lee QW Insulin; Roche Ph1 CAD Study; Lilly Ph3 TOGETHER-PsA Results

A series of cardiometabolic-related news items has been observed from Kailera Therapeutics, Diamyd Medical, Insilico, Bayer, Gan & Lee Pharmaceuticals, Roche, and Lilly. Below, FENIX provides highlights and insights for the respective news items.

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Farxiga DELIVER Label Analysis

Earlier this week, FDA approved Farxiga (dapagliflozin) to reduce the risk of CV death, hospitalization for HF, and urgent HF visit in adults with HF, regardless of baseline LVEF (view updated Farxiga label; previous FENIX insight). The label extension was based on positive results from the Ph3 DELIVER trial (view CT.gov record). Recall, in February 2023, Forxiga received EU approval for the expanded HF indication (previous FENIX insight). Below, FENIX has conducted a Farxiga HF label analysis in the context of the Jardiance HF indication.

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