Tag Archives: Forxiga

DAPA-HF is a Home Run, But Results Remain Unpublished

Full results from AstraZeneca’s Farxiga DAPA-HF trial were presented at ESC 2019. Data from the trial showed an impressive 26% RRR (p<0.0001) in the primary composite endpoint (CV death or worsening of heart failure) with both components contributing to the highly statistically significant result. Additionally, Novartis presented results from the Entresto PARAGON-HF trial (patients with HFpEF) which narrowly missed statistical significance on the primary endpoint but showed benefit in key subpopulations. Of note, it appears that DAPA-HF has not yet been published in any scientific journal, and the p-value in the AZ press release did not exactly match what was presented during ESC 2019. Below, FENIX provides thoughts on the DAPA-HF and PARAGON-HF results in the context of the evolving HF market.

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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DAPA-HF @ ESC 2019 on Sunday Sept 1

AstraZeneca announced that the Farxiga DAPA-HF study will be presented on Sunday, September 1, 2019 the European Society of Cardiology (ESC) congress in Paris. Of note, DAPA-HF will be presented during the same session as THEMIS (Brilinta in patients with established CAD and T2DM) and PARAGON-HF (Entresto in patients with HFpEF). On August 20, AZ announced positive topline results from the trial. FENIX will be providing an in-depth analysis of the data following the ESC presentation.

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.

DECLARE Approval Timeline Moved Up; AZ Q2 ’19 Earnings Update

AZ hosted its Q2 ’19 earnings call and provided updates to its diabetes commercial, clinical, and regulatory activities. Importantly, AZ updated the DECLARE US/EU regulatory decision timelines which are now both anticipated in H2 ’19 (previously said to occur in 2020). AZ also disclosed it has a new Ph1 GLP-1RA compound (MEDI7219). Discussion regarding the Farxiga T1DM CRL was minimal. Below, FENIX provides diabetes-related highlights and insights from the call.

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.