Category Archives: SGLT2i

High-dose Trulicity CHMP Opinion this week?; CHMP Agenda July 20-23

The CHMP agenda for this month (July 20-23) has been released, and it includes one notable item, a potential high-dose Trulicity CHMP opinion, as well as several other agenda items. Below, FENIX provides diabetes-related highlights and insights from the July 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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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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Purchase Blast$599.00

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Bayer Reports Finerenone T2DM DKD Renal Outcomes Trial Topline Results (FIDELIO-DKD) ; EMPEROR-Reduced at ESC 2020

Bayer announced positive topline results from its Ph3 FIDELIO-DKD trial evaluating finerenone in T2DM with CKD. Finerenone demonstrated a delayed progression to the primary composite endpoint (onset of kidney failure, sustained decrease of eGFR ≥ 40% from baseline over at least 4 weeks, or renal death). The specific risk reduction was not disclosed. Below, FENIX provides thoughts on the FIDELIO-DKD results including a curious observation that the press release did not mention anything about safety in the trial.

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.

CREDENCE Approved by EC

Late yesterday, Janssen’s EU partner, Mundipharma, announced the European Commission approved the Invokana renal protection indication based on results from the CREDENCE  renal outcomes study (view the updated summary of product characteristics here). Recall, CREDENCE received a positive CHMP opinion on May 29, 2020 (previous FENIX insight). Below, FENIX provides brief thoughts on the EC approval and expanded market potential.

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-HF CHMP Opinion This Week?; CHMP Agenda June 22-25

The CHMP agenda for this month (June 22-25) has been released, and it includes one notable item, a potential DAPA-HF CHMP opinion, as well as several other agenda items. Below, FENIX provides diabetes-related highlights and insights from the June 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.

Thoughts on Jardiance EMPERIAL 6MWT Full Results

Late last week, BI/Lilly announced full results from the EMPERIAL-Reduced and EMPERIAL-Preserved trials, evaluating Jardiance on exercise ability in patients with heart failure. Recall, in December 2019, BI/Lilly disclosed that both EMPERIAL trials failed to show a statistically significant improvement in the 6-minute walk test (previous FENIX insight). Full results of the studies were presented during the ESC HFA Discoveries program. Below, FENIX provides thoughts on the EMPERIAL trial results in the context of Novartis’s Entresto 6MWT study as well as potential readthrough to AstraZeneca’s DETERMINE 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.

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.

VERTIS-CV Questions Remain; Dexcom Partnered for COVID-19 Remote Monitoring; New Libre RWE; Nemaura Continues PR Blitz; ADA Key Press Releases (June 16)

On the final day of ADA 2020, four diabetes-related news items were observed: full results from the ertugliflozin VERTIS-CV study, Dexcom partnered with KORE for COVID-19 remote monitoring, additional Libre RWE, Nemaura continues on its ADA PR blitz. 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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Purchase Blast$599.00

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

CREDENCE Receives Positive CHMP Opinion; Metformin ER Recalled Over NDMA Impurities

Two diabetes-related news items have been observed: according to the CHMP meeting highlights, Janssen’s Invokana/Vokanamet renal protection indication (CREDENCE) has received a positive CHMP opinion and FDA announced a voluntary recall for certain lots of metformin ER due to nitrosamine impurity N-Nitrosodimethylamine (NDMA) impurities. Of note, FDA indicated there are five firms who have been contacted about the recall but additional manufacturers remain unaffected. Below, FENIX provides brief thoughts on the the CREDENCE CHMP opinion and insight on a potential readthrough to branded OADs following the metformin recall.

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.

CREDENCE Once Again on the CHMP Agenda; CHMP Agenda May 25-28

The CHMP agenda for this month’s meeting (May 25-28) has been released, and it includes two notable items: the Invokana/Vokanamet renal protection indication (CREDENCE) and the Saxenda adolescent label extension. Of note, the May 2020 CHMP meeting agenda was just posted today despite the fact that the meeting started on May 25. Below, FENIX provides diabetes-related highlights and insights from the May 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.

New Jardiance Post-MI HF Trial (EMPACT-MI)

BI/Lilly announced plans to conduct a new pragmatic trial, called EMPACT-MI, to investigate the effect of Jardiance on heart failure patients ±T2DM who have been hospitalized with an acute MI. The trial is being conducted in collaboration with the Duke Clinical Research Institute, and is being led by Adrian Hernandez and Javed Butler. A preliminary search of CT.gov did not show any results for EMPACT-MI, and BI/Lilly did not provide a timeline of when it plans to initiate the study. Below, FENIX provides thoughts on EMPACT-MI, including BI/Lilly’s motivation to conduct such a trial as well as potential readthrough to 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.