Tag Archives: empagliflozin

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 EMPEROR-Reduced Approved by FDA

BI/Lilly announced Jardiance received FDA approval for the treatment of HFrEF based on results from the EMPEROR-Reduced CVOT. The indication from the updated label reads “to reduce the risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure and reduced ejection fraction.” Of note, the approval comes ~3 weeks ahead of the projected PDUFA date (September 9, 2021). In June 2021, BI/Lilly received EC marketing authorization for Jardiance as a treatment for adults with symptomatic chronic HFrEF.

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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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EMPA-REG OUTCOME Post Hoc Analysis; Abbott Sponsors ADA Health Equity Initiative; Nemaura Launches BEAT Platform and Updated Company Website Ahead of US proBEAT Launch

Three diabetes-related news items have been observed: BI and Lilly announced results from a post hoc analysis of the EMPA-REG OUTCOME trial; Abbott and ADA announced Abbott is the first anchor sponsor of the Health Equity Now (HEN) platform with a $5M contribution towards addressing health disparities for PWD; and Nemaura Medical announced the relaunch of its company website and the launch of its BEAT diabetes website. Below, FENIX provides highlights and insights for the respective news items.

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EMPEROR-Reduced Similarly Positive to DAPA-HF

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.

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Merck In-licenses Hanmi’s Dual Agonist for NASH; Generic Empagliflozin Tentative Approval

Two diabetes-related news items have been observed: Merck announced it has entered into an exclusive licensing agreement with Hanmi for the development and commercialization of efinopegdutide, a QW GLP-1/glucagon dual agonist for the treatment of NASH (formerly HM12425A and JNJ-64565111) and Lupin received tentative FDA approval for its generic empagliflozin (view article). Below, FENIX provides thoughts on why Merck has Janssen and Novo to thank for the favorable deal terms.

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Empa T1DM Discontinued; Lilly Q1 ’20 Earnings Update; AZ Initiates Farxiga COVID-19 Trial

Lilly hosted its Q1 ’20 earnings call and provided updates to its diabetes business. Of note, Lilly disclosed that the empa T1DM program has been discontinued. Separately, AstraZeneca announced plans to evaluate Farxiga as a treatment for hospitalized COVID-19 patients who are at increased risk of complications, such as organ failure. The trial is being conducted at Saint Luke’s Mid America Heart Institute and led by Mikhail Kosiborod. Below, FENIX provides highlights and insights from the Lilly earnings call as well as thoughts on the new AZ trial.

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JPM 2020 Day 4: Lexicon and Hanmi; Generic Jardiance Tentative Approval

On the final day of JPM 2020, there was a single diabetes-related presentation from Lexicon, which highlighted the upcoming CDER decision on sotagliflozin in T1DM as well as the expansion of the SOLOIST-WHF trial to include non-T2DM patients. Furthermore, Hanmi’s presentation at JPM was not webcast, but the company issued a press release with highlights of its obesity and NASH pipeline. Separately, FDA recently granted tentative approval to Alembic LTD for a generic version of BI/Lilly’s Jardiance. Below, FENIX provides highlights and insights from the respective news items including additional insight and context from the ongoing litigation between BI and Alembic.

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Jardiance EMPERIAL Studies Fail to Show HF Symptom Improvement

Boehringer Ingelheim and Lilly announced that the Jardiance EMPERIAL-Preserved and EMPERIAL-Reduced trials failed to meet the respective primary endpoints. Recall, these trials evaluated the impact of Jardiance on the 6-minute walk test in T2DM and non-T2DM patients with HFpEF and HFrEF. Below, FENIX provides thoughts on the failed EMPERIAL studies in the context of BI/Lilly’s ongoing EMPEROR HF outcomes studies as well as readthrough to AstraZeneca, Janssen, and Lexicon.

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