Tag Archives: Invokana

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.

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 and Sanofi’s Bs-Aspart up for CHMP Opinion; CHMP Agenda April 28-30

The CHMP agenda for this month’s meeting (April 28-30) has been released, and it includes two notable items up for CHMP opinion: Invokana/Vokanamet renal protection indication (CREDENCE) and Sanofi’s bs-aspart initial application. Of note, the April 2020 CHMP meeting agenda was just posted today despite the fact that the meeting started yesterday. Below, FENIX provides diabetes-related highlights and insights from the April 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.

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.

New G&L Bs-Glargine Ph1 Trial to Support Approval; J&J and Abbott Q4 ’19 Earnings Updates; New Medtronic AHCL Study; Biocon Generic Dapa Tentatively Approved by FDA

A series of diabetes-related news items have been observed including Gan & Lee completed a Ph1 biosimilarity study for its glargine, earnings calls from Johnson & Johnson and Abbott, Medtronic initiated a new advanced hybrid closed-loop study, and Biocon received tentative approval for generic dapagliflozin. Below, FENIX provides diabetes-related highlights and insights from the calls including thoughts on how the G&L study appears to be in-line with FDA’s thinking on biosimilar insulins.

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.

Janssen Partners for Invokana DKD Promotion; BI/Lilly Update Alliance Terms

Janssen and Vifor Pharma announced a US commercial partnership where Vifor will promote Invokana to nephrologists based on the new CREDENCE DKD indication. Additionally, BI/Lilly disclosed plans to “modernize” their current alliance with a focus on the commercialization of Jardiance in T2DM, heart failure, and chronic kidney disease. Below, FENIX provides context and insights surrounding these announcements. Vifor to Target Nephrologists for Janssen’s Invokana Janssen announced a partnership with Vifor Pharma, a global pharmaceutical company with a focus in nephrology, iron deficiency, and cardio-renal therapies. As a part of the agreement, Vifor’s dedicated nephrology salesforce will promote Invokana to nephrologists. Janssen will……

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.

J&J Q3 ’19 Earnings Update

Johnson & Johnson hosted their Q3 ’19 earnings call (press release) and briefly discussed the Invokana franchise. Of note, J&J only briefly mentioned the recent Invokana DKD approval based on results from the CREDENCE trial. Below, FENIX provides highlights and diabetes-related 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.

FENIX Analysis: Invokana CREDENCE Promotion

Yesterday, Janssen announced FDA approval of the Invokana renal protection indication based on results from the CREDENCE trial. Following the approval, Janssen has already updated the Invokana patient and HCP websites with CREDENCE being front and center. Below, FENIX analyzes the updated messaging and provides insights into the impending field launch for the new renal protection 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.

CREDENCE Label Update for Invokana is a Big Win for Janssen

Janssen announced FDA approval of a new Invokana indication to reduce the risk of kidney disease, CV death, and heart failure hospitalizations in T2DM patients who have diabetic nephropathy with albuminuria. Recall, FDA granted priority review to the CREDENCE sNDA shortening the review time to 6 months. CREDENCE is the second first-pass priority review approval in a row for diabetes following Novo’s Rybelsus (oral semaglutide) on Sept 20. Below, FENIX provides thoughts on the new indication and SGLT2i market implications with special attention to the Invokana 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.

Invokana CREDENCE Filing Accepted by EMA; Dexcom Wins Patent Dispute with AgaMatrix

Last week, two key news items were observed including the Invokana CREDENCE EMA filing acceptance and resolution to the Dexcom/AgaMatrix patent dispute litigation. Below, FENIX provides context and analysis for these 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.

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.