Tag Archives: SGLT2i

Novo Reports Topline Cagrisema T2DM Data; Additional Nimacimab Results; Medtronic Expands 780G Access; SanegeneBio Partners with Roche; NMPA Approves Sciwind’s Ecnoglutide in T2DM

A series of cardiometabolic-related news items has been observed from Novo Nordisk, Skye Bioscience, Medtronic, SanegeneBio/Roche, and Sciwind Biosciences. Below, FENIX provides highlights and insights for the respective news items, including a hypothesis around Novo’s cagrisema strategy.

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Novo’s Hiring Freeze; UK Advocates for SGLT2is for Treatment of T2DM

Two cardiometabolic-related news items have been observed: Novo Nordisk enacted a hiring freeze (view article); and NICE recommended SGLT2is as a first-line therapy for T2DM in UK (view press release). Below, FENIX provides highlights and insights for the respective news items.

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Abbott and Novartis Q2 ’24 Earnings

Two cardiometabolic-related news items have been observed: Abbott (press release; infographic) and Novartis (press release; slides) hosted their respective Q2 ’24 earnings calls. Below, FENIX provides highlights and insights about the respective items.

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ADA 2024 Key Press Releases (June 24)

On the final day of the ADA 2024 conference, nine cardiometabolic-related news items have been observed from Novo Nordisk, Adipo Therapeutics, Trinity Biotech, Alnylam, Viking, Teva, Teladoc Health, and CHMP. Below, FENIX provides context and analysis for the announcements, including thoughts on the potential FLOW label.

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Novo London, Tandem, and Lexicon Q1 ’24 Earnings

Three cardiometabolic-related news items have been observed: Novo hosted its post-Q1 ’24 earnings London analyst event (view webcast); and Tandem (press release) and Lexicon (press release) hosted their respective Q1 ’24 earnings calls. Below, FENIX provides highlights and insights for the respective news items.

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Viatris’s Generic Dapagliflozin and Lilly’s Trulicity Pediatric Extension Receive Positive CHMP opinions; Medtronic’s Wearable Partner Files for Bankruptcy; Nemaura Looks to Raise Additional Capital

Four cardiometablic-related news items have been observed: Viatris’s generic dapagliflozin received a positive CHMP opinion for the treatment of T2DM, HF, and CKD (view opinion); Lilly’s Trulicity received a positive CHMP opinion for a label extension to include patients ages 10 years and older (view opinion); Medtronic’s wearable partner, Rockley Photonics Holdings Limited, has filed for bankruptcy (view Form 8-K); Nemaura announced it has entered into a definitive agreement of ~$8.4M registered direct offering and concurrent private placement with two healthcare-focused US institutional investors (view press release). Below, FENIX provides highlights and insights including thoughts on an acquisition opportunity for Medtronic.

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Sema to Replace Metformin as 1L in T2DM?

As a follow-up to Novo’s oral semaglutide ASCEND PLUS primary prevention CVOT being posted to CT.gov (previous FENIX insight), FENIX has conducted an analysis, including thoughts on how Novo may be looking to displace metformin as 1L oral treatment for T2DM.

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Invokana Boxed Warning Removed

The Invokana franchise US labels have been updated (view Invokana label here), and the Boxed Warning for lower limb amputations has been removed. However, it should be noted that warnings for lower limb amputations are still listed under “warnings and precautions.” Below, FENIX provides an overview of the Invokana franchise label updates as well as thoughts on the impact of the Boxed Warning removal.

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Janssen Jumps Into Non-T2DM HF Arena With Innovative Invokana Trial Design (CHIEF-HF) To Rival BI/LLY and AZ

Janssen announced plans to enter the SGLT2i non-T2DM HF arena with “the first-ever completely decentralized, mobile, indication-seeking clinical study” called CHIEF-HF (Canagliflozin: Impact on Health Status, Quality of Life and Functional Status in Heart Failure). According to the press release, Janssen believes it can use this new trial to support an Invokana non-T2DM heart failure (HF) indication. Of note, the trial is not yet listed on CT.gov. Below, FENIX provides thoughts on this first-of-a-kind trial design as well as insight on Janssen’s attempt to push regulatory boundaries and keep pace with BI/LLY and AZ.

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AZ Initiates Unbranded HF Education Campaign

AstraZeneca announced the initiation of a new unbranded disease state education (DSE) campaign called “Diabetes Can Break Your Heart,” which focuses on heart failure (HF) risk in patients with T2DM. The DSE includes a new website as well as a national bus tour that will stop at select cities throughout 2020 but starts in Philadelphia at the upcoming AHA conference (November 16-18). Below, FENIX provides insights about the new AZ HF campaign including a comparison to BI/Lilly’s initial Jardiance DSE for its CV death risk reduction indication.

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