Category Archives: SGLT2i

Thoughts on ADA 2020 Standards of Care

ADA recently updated its Standards of Medical Care in Diabetes for 2020, which includes key additions across multiple drug classes. Of note, the standards now include a recommendation for initiating SGLT2i or GLP-1RA therapy in patients with ASCVD, HF, or CKD (SGLT2i only) who are already at their A1C goal. Interestingly, while the guidelines were updated to include discussion of the CANVAS/R, CREDENCE, DECLARE, REWIND, and CARMELINA trials, CAROLINA and DAPA-HF trials were not addressed. Below, FENIX provides thoughts and market implications for selected guideline updates.

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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Mylan Challenges Novo on Victoza Patent Dispute; Lexicon, Poxel, MannKind, and Diamyd Clinical Data

Mylan has challenged a patent for Novo Nordisk’s Victoza. Additionally, several diabetes players including Lexicon, Poxel, MannKind, and Diamyd have announced clinical results before the holiday break. Below, FENIX provides contexts and insights on these news items.

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Medtronic Acquires Klue; New Tandem SGLT2i+Closed-loop Trial

Medtronic announced it has completed the acquisition of “Klue,” a company developing behavior tracking technology to “provide real-time insights into when a person is consuming food.” Additionally, a new CT.gov record has been observed for an investigator-initiated trial evaluating Tandem’s closed-loop systems (Basal IQ and Control IQ) in T1DM patients on an SGLT2i. Below, FENIX provides thoughts on the news items including how Klue may help to enhance Medtronic’s PCL while still leaving some potential hurdles.

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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Tirzepatide CVOT vs. Trulicity; Lilly 2020 Guidance Summary

Today, Lilly hosted its 2020 Guidance and Investment Community Meeting and discussed potential key milestones for 2020. Importantly, Lilly disclosed that its tirzepatide CVOT will be conducted H2H vs. Trulicity. Below, FENIX provides highlights and insights from the call including thoughts on why a tirzepatide CVOT vs. Trulicity makes sense.

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 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.

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Purchase Blast$599.00

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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.

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.

Lexicon Loses Sota T1DM Formal Appeal

Lexicon Pharmaceuticals announced the FDA’s Office of New Drugs has denied Lexicon’s appeal of the CRL issued for sotagliflozin in T1DM. Lexicon’s stock fell ~15% in response to this news. In a conference call hosted shortly after the announcement, Lexicon outlined next-steps for sotagliflozin in T1DM and provided comments on additional indications and partnership opportunities. 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.

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Purchase Blast$599.00

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

Novo 2019 Capital Markets Day Highlights and Analysis

Novo hosted its 2019 Capital Markets Day and provided updates on the strategic direction of the company through 2025 including commercial activities and R&D strategy. Of note, Novo provided clarity on Rybelsus positioning vs. Ozempic and competitor products as well as details on novel drug delivery technologies, including two oral peptide delivery methods being developed at MIT and the semaglutide+AM833 injection device. Below, FENIX provides details 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.

Lexicon @ Stifel; First Presentation Since Empa T1DM Adcom

Lexicon participated in the 2019 Stifel Healthcare conference and provided brief updates on the sotagliflozin regulatory situation including commentary regarding the recent BI/Lilly empa T1DM adcom. Recall, the empa T1DM adcom ended in a 2-14 vote not favoring approval. Below, FENIX provides highlights and insights from the Stifel event including potential readthrough to the ongoing sotagliflozin appeal with the Office of New Drugs.

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.

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.

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.