Category Archives: SGLT2i

CRL for Empa 2.5mg in T1DM

BI/Lilly announced late Friday that the FDA has issued a CRL for the T1DM sNDA of empagliflozin 2.5 mg (press release). Of note, the CRL indicates that “the FDA is unable to approve the application in its current form.” Below, FENIX provides thoughts on the empa T1DM CRL in the context of other SGLTi T1DM initiatives.

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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Thoughts on Lexicon Closing Its Sota CVOTs

Yesterday, Lexicon announced the early close out of its sotagliflozin CVOTs, SCORED and SOLOIST, mainly due to operational challenges with COVID-19 and the low likelihood of finding a commercialization partner (press release). Below, FENIX provides highlights and insights surrounding this update, including the potential generalization to BI/Lilly’s EMPEROR HF studies, and larger thoughts on Lexicon’s pivot away from 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.

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Purchase Blast$599.00

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Zyquista T1DM CRL stands (Lexicon Q4 ’19 Earnings Update); Jardiance CKD Fast Track Designation

Lexicon hosted its Q4 ’19 earnings call (press release) and provided brief updates on the Zyquista T1DM CRL appeal as well as the T2DM Ph3 development program. Additionally, Lilly announced the FDA’s fast track designation to Jardiance in chronic kidney disease (press release). Of note, CDER reaffirmed the FDA’s decision on the Zyquista T1DM CRL, stating the NDA application in T1DM could not be approved in its current form. Below are the key highlights and insights from Lexicon’s earnings call as well as the Jardiance CKD fast track designation, especially in the context of other ongoing renal outcomes trials.

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.

New dapa HF study (DICTATE-AHF) in T2DM patients with acute decompensated heart failure

Last week, a Ph3 dapagliflozin trial (DICTATE-AHF) in T2DM patients with acute decompensated heart failure (ADHF) was observed on CT.gov. Of note, the study is assessing the decongesting effects of dapagliflozin and protocolized diuretic therapy in ADHF patients. Below, FENIX provides thoughts on this new trial in the context of other SGLT2 HF trials and what it could mean for 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.

CREDENCE CHMP Opinion This Week? DAPA-HF Filed with EMA; CHMP Agenda February 24-27

The CHMP agenda for this month’s meeting (February 24-27) has been released, and it includes two notable items (CREDENCE opinion and DAPA-HF filing) as well as some others. Below, FENIX provides diabetes-related highlights and insights from the February 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.

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.

Merck Keeps Januvia As it Spins Off Other Legacy Brands

In conjunction with Merck’s Q4 and FY 2019 earnings call, the company announced plans to create a spin-off company with assets from Merck’s Women’s Health, Legacy Brands, and Biosimilars business. There was no mention of Merck/Pfizer’s Steglatro franchise on the call. Below, FENIX provides highlights from the Merck earnings call as well as insights as to why Januvia is not included in the spinoff company.

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.

Thoughts on New CVS Program to Eliminate Diabetes Drug OOP Costs

CVS Health recently announced a new program called “RxZERO,” which is said to completely eliminate all out of pocket costs (OOP) for diabetes prescription drugs. According to the press release, RxZERO will provide the benefit to members “without raising costs for the plan sponsor or increasing premiums or deductibles for all plan members.” Below, FENIX provides thoughts on the RxZERO program in the context of the ongoing drug pricing debate in the US.

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.

Lilly and Roche Q4 ’19 Earnings Updates

Lilly and Roche hosted their respective Q4 and FY 2019 earnings calls and provided updates to their respective diabetes businesses. Of note, Lilly disclosed additional information regarding the impending initiation of the tirzepatide T2DM CVOT, and Roche indicated it plans to pursue smartphone pump control. Below, FENIX provides highlights and insights from the calls including thoughts on how Lilly’s tirzepatide CVOT trial design compares to the 2008 FDA Guidance.

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.

Trijardy XR (empa/lina/met XR FDC) Approved; Trijardy Label and Market Analysis

Late yesterday, Boehringer Ingelheim and Lilly announced FDA approval for their empagliflozin+linagliptin+metformin XR triple FDC, branded as “Trijardy XR.” Below, FENIX has conducted a Trijardy XR label analysis which includes a comparison to AstraZeneca’s Qternmet XR (dapa+saxa+met XR) as well as thoughts on the potential impact of the triple FDCs on the OAD market segment.

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.