Tag Archives: HFpEF

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.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Heart Failure: Tirzepatide vs. Semaglutide HFpEF Ph3 Trial Analysis

Lilly has recently initiated the Ph3 tirzepatide HFpEF trial, called SUMMIT (view CT.gov record). Recall, during Lilly’s 2021 guidance call (December 15, 2020), Lilly first disclosed plans to develop tirzepatide for the treatment of HFpEF (previous FENIX insight). Below, FENIX provides an overview of SUMMIT, including a comparative analysis with Novo’s semaglutide HFpEF trial (STEP HFpEF).

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

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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.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.