Category Archives: SGLT2i

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.

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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.

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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.

ADA 2019 Abstract and Session Titles Available

ADA 2019 abstract and session titles are available through the ADA desktop app. According to the ADA website, full abstract text will be available Tuesday, June 4 at 5:00 pm ET.

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.

AZ Triple Combo Approved as Qternmet XR; Qtern Label Update

AstraZeneca announced FDA approval for its triple combination, Qternmet XR (dapagliflozin+saxagliptin+metformin XR), for improvement of glycemic control in patients with T2DM (Qternmet XR FDA label). Additionally, the Qtern label (dapagliflozin+saxagliptin) was updated with 3 notable changes: 1) eGFR cutoff lowered to 45ml/min/1.73m2 which is now consistent with Farxiga, 2) a new 5mg dapa/5mg saxa strength is now available, and 3) the indication no longer requires dapa failure or concurrent use of dapa and saxa. Below, FENIX provides thoughts on the new triple combination FDC and Qtern label 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.

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.

No Update on Sota CRL Resolution Timeline; Lexicon Q1 ’19 Earnings Update

Lexicon hosted its Q1 ’19 earnings call and briefly discussed the ongoing US regulatory situation for sotagliflozin following the March 22, 2019 CRL. Below, FENIX provides highlights and insights from the call including thoughts on the T2DM submission and approval timeline.

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 and Pfizer Q1 ’19 Earnings Updates

Merck and Pfizer hosted their respective Q1 ’19 earnings calls. Both companies only briefly discussed their diabetes-related businesses. Below, FENIX provides highlights from the calls.

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.

REWIND Filed; Empa T1DM, Nasal Glucagon Delayed; Lilly Q1 ’19 Earnings Update

Lilly hosted its Q1 ’19 earnings call and provided updates to its diabetes business. Of note, Lilly disclosed that it submitted REWIND (US and EU), URLi (EU, Japan, and maybe the US), a connected prefilled pen (US), and the empa+lina+metXR triple combination (US). Furthermore, Lilly also disclosed two regulatory delays. FDA refused to accept the sNDA for Jardiance in T1DM for “technical reasons,” and the review for Lilly’s nasal glucagon rescue product was extended by 3 months after FDA requested additional data. Below, FENIX provides thoughts and context to the significant Q1 ’19 regulatory events in diabetes.

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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Zynquista Approved in EU for T1DM

Sanofi and Lexicon announced they received EU marketing authorization for the commercialization of Zynquista (sotagliflozin) in T1DM (200mg and 400mg doses). Recall, on February 28, 2019, CHMP adopted a positive opinion. Zynquista is now the second SGLTi to be approved by EU regulatory authorities. On March 25, 2019, Forxiga was granted approval. Below, FENIX provides brief thoughts on the approval.

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.