Category Archives: SGLT2i

Sota adcom vote split 8-8; on-time approval now in question

Today, the FDA advisory committee panel split the vote (8-8) on whether the sotagliflozin benefit in T1DM outweighs the risks. Of note, the clinicians who treat glycemic control and T1DM tended to vote “yes” while the cardiologists and biostatisticians tended to vote “no.” Below, FENIX provides key highlights of the FDA adcom as well as market implications and read-through to the other SGLT inhibitors being developed for T1DM.

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.

New Trulicity Label Update: lower hypo cutoff, AWARD-10, and pre-filled syringe discontinuation

The Trulicity label has recently been updated with 3 major changes: 1) lower rates of hypoglycemia based on moving the cutoff from <70mg/dL to <54mg/dL, 2) inclusion of AWARD-10 data (add-on to SGLT2i), and 3) discontinuation of the pre-filled syringes. Below, FENIX provides analysis of the Trulicity label update including a focus on the broader market implications of lowering the hypo cutoff. Trulicity hypo label data improves competitive messaging vs. Ozempic The Trulicity label was updated with new, lower hypo rates using a lower hypo cutoff to match Ozempic and Bydureon. In the old Trulicity label, the cutoff was high……

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.

$LXRX Trading Halted Ahead of Sotagliflozin FDA Adcom

Lexicon stock trading has been halted ahead of today’s sotagliflozin T1DM FDA adcom. The previous close was $7.70. FENIX will be providing a full analysis of the adcom.

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.

FENIX Analysis: Sotagliflozin FDA Adcom Briefing Documents

Briefing documents for the Sanofi/Lexicon sotagliflozin in T1DM FDA adcom were posted today in advance of the January 17, 2019 meeting. As anticipated, FDA’s primary concern appears to be the increased risk of DKA with sotagliflozin; however, Sanofi/Lexicon’s mitigation strategy is projected to quell the concerns of the FDA adcom voting panel. Below, FENIX provides further analysis of the briefing documents, and in light of this evidence, FENIX predicts the results of the adcom will be positive for Sanofi/Lexicon. Executive Summary The 16-member panel will be asked to respond to 4 discussion questions (sota benefits for T1DM, concern for risk of DKA, differences between……

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.

JPM 2019 Day 2: LLY, SNY, LXRX, ABT, PODD, MYL

The second day of the 2019 J.P. Morgan Healthcare conference included diabetes-related presentations from Lilly, Sanofi, Lexicon, Mylan, Abbott, and Insulet. Separately, Lilly announced plans to further increase drug pricing transparency using Trulicity TV DTC. The commercials will include a portion directing patients to a Lilly website for more information on list price and average copays. Below, find a topline summary of key JPM takeaways by company followed by more in-depth coverage. In case you missed it, here is a link to FENIX’s Day 1 JPM 2019 insights. Lilly Lilly’s CEO provided a brief introduction to the company and referenced the……

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.

JPM 2019 Day 1: DXCM, MDT, JNJ, MRK; New Bigfoot Deal with Lilly

The first day of the 2019 J.P. Morgan Healthcare conference kicked off with diabetes-related presentations from Dexcom, Medtronic, J&J, and Merck. Additionally, Bigfoot announced a non-exclusive license with Lilly for inclusion of Lilly RAI in Bigfoot’s connected care ecosystem and Ascensia entered into an agreement with POCTech for CGM distribution in 13 undisclosed geographies. Also of note, FENIX provides a brief discussion on an early stage CGM company called Glutalor which has David Simmons, former Vice President and Chief Medical Officer at Ascensia Diabetes Care, on the scientific board. Below, find a topline summary of key takeaways by company followed by more in-depth……

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.

Lilly 2019 Guidance Summary

Today, Lilly hosted its 2019 Guidance and Investment Community Meeting and discussed potential key milestones for 2019. Importantly, Lilly announced late stage development plans in obesity and NASH and provided more information on the Ph3 dose titration for its QW injectable GIP/GLP-1 dual agonist tirzepatide. Connected care was also featured, and several comments were made on guidelines updates and new PBM coverage positively affecting Trulicity and Jardiance in 2019. Below, FENIX provides a summary and thoughts on diabetes-related highlights from the event. 

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.

Nothing New in Sota Adcom Federal Register Announcement

Today, the FDA published a notice in the Federal Register announcing the sotagliflozin adcom for Jan 17, which was press released yesterday by Lexicon. No notable new details were provided, and the proposed indication is in-line with expectations as “…Adjunct to insulin therapy to improve glycemic control in adults with type 1 diabetes mellitus.”

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.

Sotagliflozin Adcom in T1DM Scheduled for January 17, 2019

Today, Lexicon announced that FDA will hold an advisory committee meeting for Zynquista (sotagliflozin in T1DM) on January 17, 2019. This news is in-line with previous guidance from Lexicon’s Q3 ‘18 earnings call. Recall, the PDUFA date for Zynquista is March 22, 2019 (previous FENIX insight). FENIX will provide coverage and analysis of the FDA briefing documents as well as the adcom meeting. The following updates are occurring in the map: Adcom announcement is being added under respective map entries… If you receive our email blasts, you already have an account. Log in nowContext counts when making decisions.Purchase Blast$599.00You can read the article’s full…

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.

Thoughts on New ACC T2DM ASCVD Recommendations

The ACC published their 2018 ACC Expert Consensus Decision Pathway on Novel Therapies for CV Risk Reduction in Patients with T2DM and ASCVD in JACC. Notably, the ACC recommends SGLT2i use for potential CV benefits and GLP-1RA use for those patients who may have an unsuitable risk profile for SGLT2i use. Below, FENIX provides a winners-and-losers analysis based on the recent ACC recommendations compared to the updated ADA/EASD guidelines from October 2018.

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.