Category Archives: SGLT2i

Farxiga Receives Breakthrough Therapy Designation for CKD

AstraZeneca announced FDA granted Breakthrough Therapy Designation (BTD) to Farxiga for the treatment of chronic kidney disease in patients with and without diabetes. Below, FENIX provides thoughts on the impending DAPA-CKD regulatory review in the context of Janssen’s CREDENCE and readthrough to BI/Lilly’s EMPA-KIDNEY.

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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Dexcom Publishes G6 UK Cost-Effectiveness Data and Launches G6 in Turkey; Lifescan Launches OneTouch Amazon Storefront; Daewoong Pharma Announces Ph2 Results for Enavogliflozin; Zucara Therapeutics Doses First Patient in Preventative Hypo Study

A series of diabetes-related news items have been observed: Dexcom published results from a study evaluating the cost-effectiveness of its G6 CGM in the UK and announced the launch of G6 in Turkey; Lifescan announced the launch of its OneTouch Amazon storefront; Daewoong Pharmaceutical announced the results of a Ph2 trial evaluating enavogliflozin; and Zucara Therapeutics announced the first patient has been dosed in a Ph1 trial of ZT-01 for insulin-induced hypoglycemia. Below, FENIX provides highlights and insights for the respective news items.  

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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New Semaglutide HFpEF Trial (STEP HFpEF); DAPA-MI Posted on CT.gov; Final Day of EASD 2020 (Sept 25)

On the final day of EASD 2020, no new press releases were observed; however, during the Novo Nordisk obesity session, the speaker disclosed plans to conduct a semaglutide HFpEF study. Additionally, AstraZeneca’s DAPA-MI study has been posted on CT.gov. Below, FENIX provides insights and context from the respective news items, including thoughts on why the STEP HFpEF trial appears to fit into the new paradigm of non-outcomes-based label-enabling studies.

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

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

Apple Cites T1DM Omnipod Patient Story at Tuesday Event; Jardiance Post-MI Trial (EMPACT-MI) Receives FDA FTD; Adocia Topline Results from M1Pram Ph1b Trial Extension; Welldoc/UMD Employs AI to Identify Digital Health Habits; Oramed’s Positive Diabetes Market Survey Results; Diamyd Receives $13.9M Towards Companion Medical Shares

A series of diabetes-related news items have been observed: Apple featured a T1DM patient story during the Apple Watch portion of its event; BI/Lilly announced Jardiance has received Fast Track designation for its EMPACT-MI study; Adocia announced positive topline results from its Ph1b M1Pram extension study in PWT1D; Welldoc and the University of Maryland’s Center for Health Information and Decision System (CHIDS) announced findings from a user engagement analysis; Oramed announced results from a diabetes market survey; and Diamyd received $13.9M from its divestment in Companion Medical. Below, FENIX provides highlights and insights from the respective news items.

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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High-dose Trulicity, DAPA-HF and Gvoke up for Opinions; CHMP Agenda September 14-17

The CHMP agenda for this month (September 14-17) has been released, and it includes three notable items: high-dose Trulicity, Dapa-HF, Xeris’s Gvoke, as well as several other agenda items. Below, FENIX provides diabetes-related highlights and insights from the September 2020 CHMP agenda.

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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AZ Provides Additional DAPA-CKD Commentary During Post-Results Investor Call

Following the DAPA-CKD results, which were presented at ESC 2020 on August 30 (previous FENIX insight), AZ hosted a call with investors (view slides here). Beyond reviewing the DAPA-CKD results, AZ senior management and DAPA-CKD investigators provided commentary on the trial results and the new Farxiga market potential. Below, FENIX provides highlights from the investor call as well as additional perspective on the impact of DAPA-CKD.

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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DAPA-CKD Results Highly Positive; AZ Winning in SGLT2i LCM

Full results from the DAPA-CKD renal outcomes trial were presented at the 2020 virtual ESC conference (view AstraZeneca press release), but it does not appear the results have been published. Results demonstrated a highly impressive 39% RRR in the primary composite endpoint (sustained ≥50% decline in eGFR, ESKD, renal death, or CV death). Curiously, the CV death component of the primary endpoint failed to demonstrate a statistically significant benefit (HR=0.81; p=0.20); however, there was a statistically significant 31% RRR in all-cause mortality. Below, FENIX provides thoughts on the DAPA-CKD results in the context of the Invokana CREDENCE study (DKD), the ongoing EMPA-KIDNEY trial from BI/Lilly, and Lexicon’s SOLOIST and SCORED CVOTs.

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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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.

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

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

Invokana Boxed Warning Removed

The Invokana franchise US labels have been updated (view Invokana label here), and the Boxed Warning for lower limb amputations has been removed. However, it should be noted that warnings for lower limb amputations are still listed under “warnings and precautions.” Below, FENIX provides an overview of the Invokana franchise label updates as well as thoughts on the impact of the Boxed Warning removal.

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.

Livongo to Merge with Teladoc; AZ Partners for HF Diagnostic; ViaCyte Partners with Gore for Novel Membrane Development; Teva Q2 ’20 Earnings Update

A series of diabetes-related news items have been observed: Livongo and Teladoc Health announced they have entered into a definitive merger agreement; Eko announced it entered into a global partnership with AstraZeneca for a heart failure diagnostic tool; ViaCyte and Gore announced an agreement to further develop ViaCyte’s Encaptra Cell Delivery System to facilitate stem cell-derived islet replacement (press release); and Teva hosted its Q2 ’20 earnings call (press release; slides). Below, FENIX provides highlights for the respective news items including thoughts on the Livongo+Teladoc merger and insight into the AZ diagnostic partnership as a lead generation tool for Farxiga.

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.