Tag Archives: ADA

June CHMP Agenda; AstraZeneca Discontinues Oral GLP-1RA Development; Lilly Launches Insulin Affordability Awareness Campaign

Three cardiometabolic-related news have been observed: the CHMP agenda (view here) for this month’s meeting (June 19-22) has been released, including Jardiance’s EMPA-KIDNEY and Mounjaro obesity indication extensions; AstraZeneca announced it is discontinuing development of its oral, AZD0186 (view article); and Lilly announced a partnership with ADA and Adam Duvall to increase awareness of Lilly’s insulin affordability programs (view press release). Below, FENIX provides context and insight on the respective news items, including insight into how Novo’s OASIS 1 readout likely influenced AZ’s decision.

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Pfizer Hosts 2022 R&D Day; Novo Initiates 7.2mg Sema Ph3 Obesity Trial; ADA 2023 Diabetes SoC Guidelines; December CHMP Agenda

A series of cardiometabolic-related news items have been observed: Pfizer hosted a Near-Term Launches and High-Value Pipeline investor event and discussed its two oral GLP-1RAs, PF-07081532 and danuglipron (slides; webcast); Novo Nordisk initiated a Ph3 semaglutide obesity trial evaluating up to a 7.2mg QW subcutaneous dose (STEP UP; view CT.gov record); ADA announced it published the 2023 SoC guidelines in Diabetes Care (view press release; view publication); and the CHMP agenda (view here) for this month’s meeting (December 12-15) has been released. Below, FENIX provides insight on the respective news items, including the impact of the updated ADA Standards of Care guidelines.

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New ADA/EASD 2022 T2DM Guidelines; EASD 2022 Key Press Releases (Sept 23)

On the final day of EASD 2022, two key news items were observed: ADA/EASD presented the updated T2DM consensus guidelines (journal publication; download slides), placing obesity management as a key consideration; and Ionis announced AstraZeneca decided not to advance their PCSK9i (ION449; AZD8233) despite achieving positive Ph2b results (press release). Below FENIX provides insights and context from the respective announcements.

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ADA 2022 Key Press Releases (June 4)

On the second day of ADA 2022, six cardiometabolic-related news items were observed from Lilly, ADA, Insulet, vTv Therapeutics, and One Drop. Below, FENIX provides context and analysis for the announcements.

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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.

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Thoughts on ADA 2020 Standards of Care

ADA recently updated its Standards of Medical Care in Diabetes for 2020, which includes key additions across multiple drug classes. Of note, the standards now include a recommendation for initiating SGLT2i or GLP-1RA therapy in patients with ASCVD, HF, or CKD (SGLT2i only) who are already at their A1C goal. Interestingly, while the guidelines were updated to include discussion of the CANVAS/R, CREDENCE, DECLARE, REWIND, and CARMELINA trials, CAROLINA and DAPA-HF trials were not addressed. Below, FENIX provides thoughts and market implications for selected guideline updates.

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ADA Standards of Care Update: REWIND, CGM TIR Targets, and Victoza Peds

Yesterday, ADA announced updates to its Living Standards of Medical Care in Diabetes. The Living Standards of Care revision now incorporates REWIND CV data, Victoza use in pediatric patients, and the international consensus report on CGM time-in-range goals. Below, FENIX provides thoughts and market implications for each of the respective guideline updates.

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Thoughts on 2019 ADA Standards of Care

The ADA announced the publication of their 2019 Standards of Medical Care in Diabetes Care. Of note, the ADA has aligned their CVD recommendations with the ACC’s recent T2DM ASCVD recommendations. The ADA also added a new dedicated section titled “Diabetes Technology,” which includes information previously incorporated in the “Glycemic Targets” section. The ADA also provides a cost breakdown of pharmacologic treatment options. Below, FENIX has provided highlights and insights from the updated ADA 2019 Standards of Care.

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ADA 2019 Standards of Care published

Today, the ADA announced the publication of their 2019 Standards of Medical Care in Diabetes Care. Notably, the 2019 ADA Standards of Care are aligned with the recently updated ADA/EASD guidelines. FENIX will conduct an analysis and provide thoughts on the 2019 ADA Standards of Care.

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Tidepool to Support Loop; New Study on Insulin Variability in US Pharmacies

JDRF, ADA, and the Helmsley charitable trust awarded a grant for a study evaluating the variability of insulin potency in US pharmacies. Additionally, Tidepool recently announced a program to support the DIY Loop automated insulin-delivery project through an FDA-regulated manner. Below, FENIX provides a brief overview and thoughts on each new project, including Tidepool’s potential motivation.

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