Tag Archives: finerenone

Novo Nordisk and Heartseed Dose First Patient in Ph1/2 LAPiS Trial of HS-001; Finerenone Receives EU Approval for FIGARO-DKD Label Extension

Two cardiometabolic-related news items have been observed: Novo Nordisk and Heartseed announced the first patient has been dosed in the Ph1/2 LAPiS study (view CT.gov record) evaluating HS-001 in 10 patients with advanced HF caused by ischemic heart disease (view press release); and Kerendia (finerenone) has received EU approval for label extension to include CV outcomes in patients with CKD and T2DM (view Kerendia EPAR). Below, FENIX provides highlights and insights from the respective news items.

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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Lilly Partners with Sosei Heptares for Metabolic Drug Discovery; FIGARO-DKD and DELIVER Positive CHMP Opinions

Three cardiometabolic-related news items have been observed: Sosei Heptares announced an R&D collaboration with Lilly for diabetes and metabolic diseases (view press release); Bayer announced Kerendia (finerenone) received a positive CHMP opinion for the FIGARO-DKD study (view press release); AZ’s Forxiga received a positive CHMP opinion to broaden its HF indication based on results from DELIVER (view opinion). Below, FENIX provides highlights and insights on the Lilly partnership and respective positive CHMP opinions.

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 Initiates Kerendia and Jardiance Combo Trial Following Kerendia EU Approval

Bayer announced the initiation of CONFIDENCE, a Ph2 study evaluating the combination therapy of Kerendia (finerenone) and Jardiance (empagliflozin) in patients with CKD and T2DM (view CT.gov record). The trial initiation follows the recent EU approval of finerenone for CKD associated with T2DM in adults (view press release). Recall, finerenone was approved in the US in July 2021 (previous FENIX insight) and is currently under review in China and multiple other countries worldwide. Below, FENIX provides insights into the new CONFIDENCE trial, including thoughts on Bayer’s strategy to do the Ph2 trial with empa instead of dapa.

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.

Bayer Hosts Kerendia Investor Webinar

Bayer hosted its Kerendia (finerenone) investor webinar (view here), highlighting Kerendia’s clinical profile, how it fits into the treatment landscape, US market strategy, and LCM initiatives. Unsurprisingly, much of the event, including the Q&A, focused on the differentiation with the SGLT2i class. Separately, Bayer announced the initiation of a new Ph3 trial (FIONA) evaluating finerenone in pediatrics with CKD and severely increased proteinuria. Below, FENIX provides highlights from the presentation as well as additional thoughts on the Kerendia launch.

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.

Bayer and Senseonics Q3 ’21 Earnings Updates; Abbott and ADA Launch Community Initiative; Provention Bio Launches #Type1TestedPledge Campaign; Beyond Type 1 Receives $750,000 Grant

A series of cardiometabolic-related news items have been observed: Bayer (press release; slides) and Senseonics (press release) hosted their respective Q3 ’21 earnings calls; Abbott and the American Diabetes Association (ADA) announced the launch of their first joint community initiative in Columbus, Ohio; Provention Bio announced the launch of its #Type1TestedPledge Campaign for Diabetes Awareness Month; and Beyond Type 1 announced it has received a $750,000 Grant from the Helmsley Charitable Trust. Below, FENIX highlights and insights for the respective new items.

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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Kerendia Early Launch and HCP Website Analysis

Bayer has updated its Kerendia HCP website with new messaging for finerenone following FDA approval in July 2021. Recall, the Kerendia HCP website previously was active with simple “now approved” messaging and was bare aside from a link to the press release, webinar sign up, speak with a Kerendia representative, and the prescribing information. Of note, the patient website appears to be largely unchanged since the initial approval. Below, FENIX provides an analysis of the initial Kerendia HCP messaging and early Kerendia Rx data, including a time-aligned launch comparison with other key brands.

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.

Finerenone Likely to Remain an Add-on to SGLT2i; FIGARO-DKD and FIDELITY Results @ ESC 2021

Findings from the Ph3 FIGARO-DKD study were presented at ESC 2021 during a Hot Line Session and simultaneously published in the NEJM. Results demonstrated a 13% RRR in the primary composite endpoint (CV death, non-fatal MI, non-fatal stroke, or hHF). Furthermore, the FIDELITY meta-analysis from FIGARO-DKD and FIDELIO-DKD was also presented. Below, FENIX provides highlights, insights, and implications, including thoughts on if/how Bayer’s interest in Lexicon’s sotagliflozin may be evolving.

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.

Omnipod 5 Delayed; Insulet, Provention Bio, and Bayer Q2 ’21 Earnings Updates

Insulet (press release), Provention Bio (press release), and Bayer (press release; slides) hosted their respective Q2 ’21 earnings calls. Importantly, Insulet disclosed the projected Omnipod 5 FDA clearance and launch have been delayed. Below, FENIX provides highlights and insights 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.

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Purchase Blast$599.00

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

Finerenone Label and Website Analysis

Bayer recently announced 10mg and 20mg finerenone, branded as “Kerendia,” received FDA approval. The approval of finerenone is based on the positive results of the FIDELIO-DKD study which demonstrated an 18% RRR in the primary composite endpoint. Below, FENIX has conducted a Kerendia label and website 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.

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.

Finerenone Approved in US as “Kerendia”

Bayer announced the FDA approval of 10mg and 20mg finerenone, branded as “Kerendia,” to reduce the risk of sustained eGFR decline, end-stage kidney disease, CV death, non-fatal MI, and hHF in adults with CKD associated with T2DM (see logo below). The approval of finerenone is based on the positive results of the FIDELIO-DKD study and the timing comes in-line with FENIX’s projection. Recall, results from FIDELIO-DKD were presented at Kidney Week in October 2020 and demonstrated an 18% RRR in the primary composite endpoint. Finerenone is currently under review in the EU, China, and multiple other countries worldwide. FENIX will conduct a full label analysis of finerenone in the coming days once the label is available.

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.