Tag Archives: Farxiga

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.

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 Reduces Progression to T2DM; Teplizumab Continues to Delay T1DM Onset; Arecor AT247 Faster than Fiasp; ADA Key Press Releases (June 15)

Today, twelve diabetes-related news items were observed: DAPA-HF delays T2DM onset, teplizumab follow-up results, Arecor uRAI Ph1 data, new Afrezza practical data, Diasome HDV Ph2 results, Hua Medicine Ph3 GKA data, ORMD-0801 in NASH, Glytec CGM POC data, Biolinq’s first-in-human CGM data, and more. Below, FENIX provides context and analysis for the announcements.

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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Farxiga HF Indication Approved (DAPA-HF)

FDA has approved Farxiga to reduce the risk of CV death and hospitalization for heart failure in T2DM and non-T2DM patients based on results from the DAPA-HF outcomes trial (view FDA press release). The DAPA-HF approval comes just one day after FENIX’s estimated date of May 4, 2020. AstraZeneca has not issued a press release nor is the updated label available at the time of this publication. FENIX will be conducting an analysis of the new Farxiga HF indication once the updated label is available.

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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AZ CVRM Q1 ’20 Earnings Update

AstraZeneca hosted its Q1 ’20 earnings call and briefly discussed its diabetes business including the recent topline data readout from DAPA-CKD, which stopped early for overwhelming efficacy. Interestingly, AZ said it does not project DAPA-CKD filing acceptance until 2021. Below, FENIX provides highlights and insights from the call, including thoughts on why the DAPA-CKD submission is later than expected.

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 Stopped Early for Overwhelming Efficacy

AstraZeneca announced that an independent data monitoring committee (DMC) has recommended stopping the DAPA-CKD study early due to overwhelming efficacy. According to CT.gov, the early trial closeout is ~8 months ahead of the full trial completion date (initially scheduled to complete in November 2020). Below, FENIX provides thoughts on DAPA-CKD in the context of Janssen’s CREDENCE, which was also stopped early, as well as potential read through to BI/Lilly and Lexicon.

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.

AstraZeneca Q4 ’19 Earnings Update

AstraZeneca hosted its Q4 ’19 and FY ’19 earnings call and provided updates to its diabetes business. Of note, AZ disclosed it received Fast Track designation for the development of cotadutide (dual GLP-1/GCG agonist) for the treatment of NASH. Below, FENIX provides 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.

Farxiga DAPA-HF receives priority review; Fiasp pediatric approval in US; MannKind launching in Brazil

A series of diabetes-related news items were observed today from AstraZeneca, Novo Nordisk, and MannKind. AZ announced FDA filing acceptance and granting of priority review for the Farxiga DAPA-HF sNDA. According to AZ, the PDUFA date is in Q2 2020. Additionally, Novo announced US approval of Fiasp for pediatric populations. Further, MannKind announced that it has received approval of the proposed price of Afrezza in Brazil, and intends to commence marketing and distribution the week of January 13, 2020. Below, FENIX provides context and insights regarding these 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.

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.

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.

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.

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.

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.

AZ Initiates Unbranded HF Education Campaign

AstraZeneca announced the initiation of a new unbranded disease state education (DSE) campaign called “Diabetes Can Break Your Heart,” which focuses on heart failure (HF) risk in patients with T2DM. The DSE includes a new website as well as a national bus tour that will stop at select cities throughout 2020 but starts in Philadelphia at the upcoming AHA conference (November 16-18). Below, FENIX provides insights about the new AZ HF campaign including a comparison to BI/Lilly’s initial Jardiance DSE for its CV death risk reduction 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.

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.