Tag Archives: BI

BI/LLY Ph3 EASE Update – Jardiance in T1DM

Today, BI/Lilly announced positive top-line results for their two Ph3 trials in T1DM, EASE-2 and EASE-3, but they did not provide specific data results in their press release. Curiously enough, Tuesday’s ADA morning session will not be results from the Ph3 EASE trials as BI/LLY said full results from both trials will be at EASD on October 4, 2018. DKA with empa 2.5mg was “comparable to placebo”, and empa 10mg and 25mg DKA rates were “higher than placebo.” BI/LLY said regulatory options are being explored.

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FENIX Analysis: SGLT2i HF CVOTs and Stopping Early Scenarios

Currently, there are multiple ongoing, label-enabling HF CVOTs in the SGLT2i class for Jardiance, Farxiga, and Zynquista (sotagliflozin), along with other studies exploring surrogate endpoints, biomarkers, and mechanisms of action. FENIX has created a tale-of-the-tape summary of the SGLT2i HF CVOTs along with a projected timeline for filings and launches. In summary, it is believed that AZ’s DAPA-HF CVOT has a high probability of stopping early for overwhelming efficacy and thus creating a priority review scenario to leap AZ ahead of BI/LLY by 6-12 months in this important LCM opportunity. Below is a summary of the rationale and hypothesis comparing the different development approaches by SGLT2i sponsors to improve clinical outcomes in HF patients.

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BI/Lilly to Initiate New Jardiance CKD Study

Boehringer and Lilly announced a collaboration with the University of Oxford to conduct a trial (EMPA-KIDNEY) evaluating the effects of Jardiance on kidney disease progression in patients with established CKD (with and without diabetes).

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