Category Archives: SGLT2i

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.

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DECLARE Filing Accepted; AZ Q1 ’19 Earnings Update

AstraZeneca hosted its Q1 ’19 earnings call and provided updates to its diabetes business. Of note, senior management disclosed that its Farxiga CVOT (DECLARE) filings have been accepted by US and EU regulatory authorities with approvals projected in 2020. Additionally, AZ said its Farxiga HF study (Dapa-HF) is projected to read out ahead of schedule (now in H2 ’19; previously 2020). Below, FENIX provides highlights and insights from the Q1 ’19 earnings 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.

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JnJ Q1 ’19 Earnings Update

JnJ hosted its Q1 ’19 earnings call and provided a brief update to its diabetes business including the recent sNDA filing of the CREDENCE data for Invokana. Recall, the full CREDENCE results were presented at the World Congress of Nephrology on April 14, 2019. Below, FENIX provides a summary 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.

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Purchase Blast$599.00

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CREDENCE Demonstrates 30% RRR in Renal Outcomes; Nephros Likely New Priority Prescribers For Invokana

Yesterday, Janssen presented full results from the Invokana renal outcomes study, CREDENCE, at the World Congress of Nephrology and simultaneously published the results in the NEJM. The CREDENCE study demonstrated a 30% RRR in the primary composite endpoint (progression to end-stage kidney disease (ESKD), doubling of serum creatinine, and renal or CV death) and met all key secondary endpoints. Recall, in July 2018, CREDENCE was stopped early and Janssen subsequently announced it submitted an sNDA in late March 2019. Below, FENIX provides an overview of the full CREDENCE results, market implications, and the potential impact on ADA and AACE guidelines.

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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CREDENCE sNDA Filed; Priority Review Unclear

Janssen announced it has filed an sNDA for the Invokana renal outcomes study, CREDENCE. Full results from CREDENCE are scheduled to be presented on April 14 at the World Congress of Nephrology meeting. Recall, on July 16, 2018, Janssen announced that CREDENCE stopped early for positive efficacy findings. Of note, Janssen’s press release did not state whether the company requested a priority review by FDA. Below, FENIX provides thoughts on the CREDENCE filing and potential approval timelines based on whether or not FDA grants priority 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.

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.

Forxiga T1DM Approved in Europe; Sota EU T1DM Approval Imminent

AstraZeneca announced the European Commission (EC) approved Forxiga in T1DM. The news follows the positive CHMP opinion on February 1, 2019. Recall, Lexicon/Sanofi’s sotagliflozin also received a positive CHMP opinion on March 1, 2019 followed by a CRL from FDA on March 22, 2019. Below, FENIX provides thoughts on the Forxiga EU approval and readthrough to sotagliflozin and Jardiance.

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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Sotagliflozin T1DM Receives CRL From FDA

Sanofi and Lexicon announced that FDA issued a CRL for the sotagliflozin T1DM review. Lexicon subsequently hosted a call with investors but did not provide any additional insight into the content of the CRL letter. Below, FENIX provides thoughts on the sota T1DM CRL and impact to the T1DM market including a winners & losers analysis.

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.

Lexicon Quiet on Sota T1DM Review; Q4 ’18 Earnings Update

Lexicon hosted its Q4 ’18 earnings call and provided brief updates to its Zynquista (sotagliflozin) clinical and regulatory activities across T1DM and T2DM. With the impending March 22, 2019 sota T1DM PDUFA, Lexicon senior management were reluctant to make comments or answer questions on the topic. For the sota T2DM development program, Lexicon said topline Ph3 data will start reading out in Q2 ’19. 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.

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Purchase Blast$599.00

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

New Head of AZ CVRM

In AstraZeneca’s press release regarding presentations at ACC 2019, Joris Silon was listed as the company’s new SVP of the CV, renal, and metabolism (CVRM) group. Recall, in October 2018, Novo announced that Ludovic Helfgott, previous head of AZ’s CVRM business, would be joining Novo as of April 3, 2019. According to Silon’s LinkedIn profile, he took the new position as of December 2018. Below, FENIX provides thoughts on Silon’s appointment to head AZ’s CVRM group as well as the headwinds and tailwinds that he faces.

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.