Category Archives: SGLT2i

Farxiga DECLARE Positive CHMP Opinion

AstraZeneca announced it received a positive CHMP opinion for the DECLARE CVOT. AZ is anticipated to comment on the US and EU DECLARE regulatory activities during its upcoming Q2 ’19 earnings call on July 25. Below, FENIX provides brief thoughts on the impending EMA approval in the context of the ongoing FDA review.

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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HF Trial Draft Guidance Issued by FDA; Public Hearing in July 2019

FDA announced it has issued draft guidance titled, “Treatment for Heart Failure: Endpoints for Drug Development Guidance for Industry” (download HF draft guidance here). Additionally, FDA will be hosting a public workshop on Friday, July 26, 2019, from 9am to 4pm ET at the White Oak Campus.

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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High-dose Trulicity Topline Results; Jardiance Fast Track Designation for HF

Lilly announced positive topline results from its AWARD-11 study evaluating high-dose Trulicity (3.0 and 4.5mg). Separately, Boehringer Ingelheim and Lilly announced they have received Fast Track designation for the Jardiance heart failure indication based on the ongoing EMPEROR clinical trials. Of note, Lilly did not provide details on the A1C or weight reduction observed in AWARD-11. Below, FENIX provides insight and context on the Jardiance HF Fast Track designation as well as thoughts on AWARD-11 and the potential magnitude of effect with Trulicity 3.0 and 4.5mg doses.

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.

DECLARE CHMP Decision This Week; Sanofi BS-Aspart Filed in EU? CHMP Agenda Highlights

The CHMP agenda for this week’s meeting has been released, and it includes some notable diabetes decisions including AZ’s DECLARE CVOT label update (Type II variation). Additionally, there is a new application for insulin aspart which is believed to be from Sanofi. Below, FENIX provides diabetes-related highlights and insights from the 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.

ADA 2019 Key Press Releases (June 9 and 10)

14 major news items were observed over the past 2 days including Provention Bio’s teplizumab, dasiglucagon pivotal data, DECLARE and EMPA-REG subanalyses, Afrezza pediatric and fixed titration data, Tandem and Insulet hybrid-closed loop 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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Purchase Blast$599.00

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

Novo Oral Sema Data, Tirzepatide Ph2 Analyses, New Medtronic Pivotal Studies; ADA 2019 Key Press Releases (June 8)

Today, nine major news items were observed including Novo’s PIONEER 2 (vs. Jardiance) and PIONEER 4 (vs. Victoza) data readouts, new Medtronic closed-loop, and CGM pivotal trials, 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.

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.

BI/Lilly Empa+Lina+MetXR Triple FDC Filing Accepted By FDA

Boehringer Ingelheim and Lilly announced FDA accepted the NDA filing for their empagliflozin+linagliptin+metformin XR triple FDC for the treatment of T2DM. Below, FENIX provides brief thoughts on the emerging triple combination market in the context of the recent FDA approval for AstraZeneca’s QternmetXR (dapagliflozin+saxagliptin+metformin XR).

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 Priority Review for Invokana; PDUFA Projected in Late September 2019

Janssen announced that FDA granted Priority Review for the Invokana CREDENCE renal outcomes sNDA which shortens the review time to 6 months. Recall, on March 28, 2019, Janssen announced the sNDA filing which suggests the PDUFA is on or around September 28, 2019. Below, FENIX provides an updated approval timeline as well as thoughts on how a renal protection indication may help to turn around the declining Invokana franchise.

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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FENIX Analysis: SGLT2i Promotional Materials Post-AACE 2019

In the second installment of our post-AACE 2019 promotional material coverage, FENIX has conducted an analysis of SGLT2i promotional materials covering Jardiance, Farxiga, Invokana, and Steglatro as well as their respective FDCs with DPP-IVi and metformin. Of note, AZ recently updated the Farxiga patient website with a new “Hit Back-Now!” tagline which is further discussed below.

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.

JNJ 2019 Pharmaceutical Business Review

JNJ hosted its 2019 Pharmaceutical Business Review and provided updates on the company’s global pharmaceutical strategy including its diabetes and cardiovascular business. Of note, discussion on Invokana was limited with prepared remarks primarily highlighting the recent CREDENCE results. Below, FENIX provides diabetes-related highlights and insights from the presentation.

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.