Tag Archives: heart failure

Novo Nordisk and Heartseed Dose First Patient in Ph1/2 LAPiS Trial of HS-001; Finerenone Receives EU Approval for FIGARO-DKD Label Extension

Two cardiometabolic-related news items have been observed: Novo Nordisk and Heartseed announced the first patient has been dosed in the Ph1/2 LAPiS study (view CT.gov record) evaluating HS-001 in 10 patients with advanced HF caused by ischemic heart disease (view press release); and Kerendia (finerenone) has received EU approval for label extension to include CV outcomes in patients with CKD and T2DM (view Kerendia EPAR). Below, FENIX provides highlights and insights from the respective news items.

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Thoughts on Sotagliflozin HF Indication after Entresto’s PARAGON Approval

Last week, Novartis received FDA approval for expanding the Entresto label in HF beyond HFrEF (previous FENIX insight). Ahead of Lexicon’s Q4 2020 earnings later in March, FENIX provides a reminder on the recent sequence of events in HF and thoughts on how the new HF labeling for Entresto could apply to Lexicon’s SGLTi, sotagliflozin.

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Amgen Returns Omecamtiv Rights to Cytokinetics; Risk-reward for CYTK Hinges on FDA Adcom

Amgen (press release) and Cytokinetics (press release) separately announced Amgen provided notice to Cytokinetics of its intention to return development and commercial rights for omecamtiv mecarbil (cardiac myosin activator) and AMG 594 (cardiac troponin activator). Cytokinetics also hosted a call with investors to provide commentary regarding Amgen’s decision and next steps for omecamtiv. Below, FENIX provides thoughts on Amgen’s decision, in the context of other recent partnership dissolution examples, as well as implications from the upcoming Entresto FDA adcom.

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First Results for Bayer’s FIDELIO @ Kidney Week; ASN High-impact Trials Released

On Friday Oct 9, ASN posted more sessions for Virtual Kidney Week. Importantly, Bayer’s FIDELIO-DKD trial for finerenone will seemingly have first results presented during Kidney Week, rather than at Virtual AHA (previous FENIX insight). Below, FENIX provides a bit more detail and thought on a dynamic 3-4 weeks between Kidney Week and AHA.

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New Farxiga hHF Post-MI Study (DAPA-MI) Receives Fast Track Designation; Abbott and J&J Q2 ’20 Earnings Updates; Dexcom G6 Temporary Approval in Pregnancy by Health Canada

A series of diabetes-related news has been observed: AstraZeneca announced it received Fast Track designation for Farxiga to reduce the risk of hospitalization for heart failure following an acute MI based on the new DAPA-MI study, JNJ (press release; slides) and Abbott (press release) hosted their Q2 ’20 earnings calls, and Dexcom announced Health Canada provided temporary approval for use of G6 in pregnant women in response to COVID-19. Below, FENIX provides a comparative analysis of DAPA-MI relative to BI/Lilly’s EMPACT-MI study as well as highlights and insights from the other news items, notably Abbott’s commentary on Libre 2 and Libre 3.

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AZ Updates Farxiga Heart Failure Promotion on Websites

AstraZeneca has recently updated its patient and HCP websites with new messaging for its heart failure indication based on the approval of the DECLARE CVOT. Recall, in November 2019, AZ also initiated an unbranded disease state education campaign called “Diabetes Can Break Your Heart.” Below, FENIX provides analysis of the new promotion in the context of the evolving SGLT2i HF story including the DAPA-HF indication.

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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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Janssen Jumps Into Non-T2DM HF Arena With Innovative Invokana Trial Design (CHIEF-HF) To Rival BI/LLY and AZ

Janssen announced plans to enter the SGLT2i non-T2DM HF arena with “the first-ever completely decentralized, mobile, indication-seeking clinical study” called CHIEF-HF (Canagliflozin: Impact on Health Status, Quality of Life and Functional Status in Heart Failure). According to the press release, Janssen believes it can use this new trial to support an Invokana non-T2DM heart failure (HF) indication. Of note, the trial is not yet listed on CT.gov. Below, FENIX provides thoughts on this first-of-a-kind trial design as well as insight on Janssen’s attempt to push regulatory boundaries and keep pace with BI/LLY and AZ.

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BI/Lilly Initiate Jardiance Acute HF Study (EMPULSE)

BI/Lilly announced the initiation of a new Jardiance study (EMPULSE) in T2DM and non-T2DM patients who have been hospitalized for acute heart failure. Below, FENIX provides an overview of the trial as well as insights into how the EMPULSE trial appears to be a natural progression of BI/Lilly’s Jardiance LCM strategy.

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