Category Archives: GLP-1RA

ADA 2021 Key Press Releases (June 28)

On day four of ADA 2021, eight cardiometabolic-related news items were observed from Bigfoot, AZ, Mannkind, Medtronic, Senseonics, BI/Lilly, Sanofi, and REMD Biotherapeutics. Below, FENIX provides context and analysis for the announcements, including thoughts on how the ALT increases observed in REMD’s Ph2 volagidemab trial could spell disaster in Ph3.

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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Novo Dual Agonist T2DM Intentions Disclosed at ADA Investor Event; Lilly Could Pursue Hypo Claim vs. Degludec in QW Basal Ph3

Two cardiometabolic presentations from Novo Nordisk and Lilly have recently been observed: Novo hosted an ADA investor event and Lilly presented CGM data from the Ph2 QW insulin trial at ADA 2021. Below, FENIX provides insight on what Novo really hopes to accomplish vs. tirzepatide, and how Lilly may pursue a hypo reduction claim vs. degludec for its QW basal insulin.

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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Wegovy Website Analysis

There have been no cardiometabolic press releases observed yet on the second day of ADA 2021. However, it appears that Novo Nordisk has recently launched the Wegovy patient website. Of note, the HCP website is not yet live as the wegovypro.com URL redirects to NovoMedLink. Below, FENIX provides an analysis of the Wegovy patient website and insights as to when to expect a DTC campaign 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.

ADA 2021 Key Press Releases (June 25)

On the first day of ADA 2021, eleven cardiometabolic-related news items were observed from Medtronic, Lilly, AstraZeneca, CeQur, Abbott, Onduo, Glooko, Mannkind, ViaCyte, Glytec, and Akero. 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.

Jardiance HFrEF EC Approval; June 21-24 CHMP Agenda

Two cardiometabolic-related news items have been observed: BI/Lilly announced Jardiance received EC marketing authorization for the HFrEF indication; and the CHMP agenda for this month (June 21-24) has been released, and it includes one notable item, DAPA-CKD, as well as several other cardiometabolic-related entries. Below, FENIX provides highlights and insights from the respective 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

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

Wegovy Added to Evernorth Obesity Program; STEP HFpEF DM Trial Observed; JDRF Issues RFA for CGM+Continuous Ketone Monitoring; One Drop Surpasses 25B Data Points

A series of cardiometabolic news items have been observed: Evernorth announced the expansion of its Weight Management Care Value program to include Novo Nordisk’s Wegovy (2.4mg semaglutide); a new Novo-sponsored trial, referred to as STEP HFpEF DM, has been observed evaluating semaglutide in people living with HF, obesity, and T2DM; JDRF issued an RFA for the development of combination CGM + continuous ketone monitoring (CKM) devices for the use of preventing DKA in patients with T1DM; and One Drop announced it has surpassed 25B longitudinal biometric data points in its platform. Below, FENIX provides highlights and insights for 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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Purchase Blast$599.00

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Wegovy WAC Pricing Analysis

As a follow up to FENIX’s Wegovy label analysis from yesterday, FENIX provides additional thoughts on the Wegovy WAC pricing vs. Saxenda. According to Novo Nordisk’s pricing websites, both Wegovy and Saxenda are being offered at the same WAC of $1,349.02. However, since a 4-pen pack of Wegovy is for 28 days and a five-pen pack of Saxenda is for 30 days, the daily cost of Wegovy is slightly higher than that of Saxenda (see table below). Below, FENIX provides insight on why Novo would offer a premium product near pricing parity with its predecessor.

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.

Wegovy Label Analysis; Novo Investor Event Highlights

Today, Novo Nordisk hosted an investor call following its announcement late Friday (June 4) that FDA approved 2.4mg semaglutide, branded as “Wegovy,” for the treatment of obesity. The approval was based on results from the STEP Ph3a clinical trial program which demonstrated 17% weight loss after 104 weeks with 40% of patients losing ≥20 of their body weight after 104 weeks. Importantly, Novo intends to quickly launch Wegovy starting on June 10, 2021. Below, FENIX provides a Wegovy label analysis including thoughts on Novo’s decision to launch the product in five single-use autoinjector pens.

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.

Sema 2.4mg for Obesity Approved by FDA as “Wegovy”

Novo Nordisk announced the FDA approval of 2.4mg semaglutide, branded as “Wegovy,” for the treatment of obesity (view Novo press release). The approval comes exactly in-line with FENIX’s projection (previous FENIX insight). According to the press release, Wegovy is indicated “as an adjunct to diet and exercise for chronic weight management in adults with obesity (initial BMI≥30 kg/m2) or overweight (initial BMI≥27 kg/m2) with at least one weight-related comorbidity.” Novo said it plans to initiate the Wegovy US launch “later in June 2021.” The label has not yet been observed.

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.

Novo Resubmits 2.0mg High-dose Ozempic to FDA

Novo Nordisk announced it has resubmitted the sNDA to FDA for QW high-dose 2.0mg injectable semaglutide for the treatment of T2DM. Recall, in March 2021, Novo announced it received a Refusal to File letter from FDA (previous FENIX insight) after initially filing the application on January 20, 2021 (previous FENIX insight). Below, FENIX provides thoughts on the refiling.

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.