Category Archives: Topics

Thoughts on DAPA-HF Approval; Farxiga HCP Website Updated

Yesterday, FDA approved Farxiga as the first SGLT2i for the treatment of HFrEF (NYHA class II-IV) in both T2DM and non-T2DM patients. The approval was based on results from the DAPA-HF study which demonstrated a 26% RRR in hospitalization for heart failure or CV death. Below, FENIX provides thoughts on the new Farxiga HF indication, including read-through to Jardiance and the SGLT2i class, and a brief overview of the updated Farxiga HCP website.

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Semaglutide Positive Ph2 NASH Data; Novo Q1 ’20 Earnings Update

Novo Nordisk hosted its Q1 ’20 earnings call (press release; slides) and provided updates to its diabetes business including the ongoing launch of Rybelsus (oral semaglutide) and new Ph2 semaglutide NASH topline data. Unsurprisingly, much of the Q1 ’20 prepared remarks and Q&A were focused on NASH. Below, FENIX provides highlights from the call and additional thoughts on Novo’s PCSK9i/basal insulin hybrid approach.

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Farxiga HF Indication Approved (DAPA-HF)

FDA has approved Farxiga to reduce the risk of CV death and hospitalization for heart failure in T2DM and non-T2DM patients based on results from the DAPA-HF outcomes trial (view FDA press release). The DAPA-HF approval comes just one day after FENIX’s estimated date of May 4, 2020. AstraZeneca has not issued a press release nor is the updated label available at the time of this publication. FENIX will be conducting an analysis of the new Farxiga HF indication once the updated label is available.

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Novartis Oncology Q1 2020 Earnings Update

On Tuesday, April 28, Novartis held their Q1 2020 earnings call (press release / financial report / slides). Of note, Kymriah sales fell slightly versus the previous quarter (Q4 2019), possibly due to the impact of COVID-19. However, Novartis underlined its confidence in the oncology field’s “resilience” and the company’s full-year sales outlook. Below, FENIX provides thoughts on Novartis’s cell therapy program, particularly in the context of the ongoing COVID-19 pandemic.

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Dexcom/Ypsomed Partner for CGM Integration; Dexcom G6 Approved In Canada for Hospital Use; Diamyd Topline Results

A series of diabetes-related news has been observed: Ypsomed announced a partnership with Dexcom to integrate CGM data with the YpsoPump and develop a hybrid closed-loop system; Dexcom announced Health Canada has authorized use of the G6 CGM to be used in hospitals during the COVID-19 pandemic; and Diamyd announced positive preliminary results from the first part of the Ph1/2 ReGenerate-1 trial evaluating Remygen in T1DM. Below, FENIX provides highlights and insights from the respective news items.

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New Dexcom Pediatric TV DTC Campaign

A new Dexcom G6 CGM TV commercial called, “Diabetes Didn’t Come Up,” has recently been observed. Of note, this is believed to be the first time that Dexcom has created a commercial solely focused on the G6 CGM pediatric indication. Below, FENIX provides analysis of the messaging used in the TV commercial, thoughts on why the pediatric TV DTC hasn’t occurred until ~2 years after launch, and Dexcom’s peds positioning vs. Abbott Libre.

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Sanofi Bs-Aspart Receives Positive CHMP Opinion; No Update on CREDENCE

According to the CHMP meeting highlights, Sanofi’s bs-aspart has received a positive CHMP opinion. Of note, the Invokana/Vokanamet renal protection indication (CREDENCE) was not mentioned in the meeting highlights, suggesting additional questions were asked to the sponsor. Below, FENIX provides brief thoughts on the positive CHMP opinion for Sanofi’s bs-aspart.

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Tandem Diabetes Care Q1 ’20 Earnings Update

Tandem Diabetes Care hosted its Q1 ’20 earnings call and provided updates to its business. Of note, Tandem disclosed that projected approvals for its remote bolus mobile app and next-gen t:sport pump have been delayed due to the COVID-19 pandemic. Below, FENIX provides highlights and insights from the call.

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Roche mySugr Pro Free During COVID-19 Pandemic

Roche announced it is offering free access to mySugr Pro as part of an effort to improve remote diabetes management during the COVID-19 pandemic. According to Roche, free access to mySugr Pro will be granted through September 20, 2020. Below, FENIX provides brief thoughts on Roche’s COVID-19 response and how it appears to be a play for lead generation.

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CREDENCE and Sanofi’s Bs-Aspart up for CHMP Opinion; CHMP Agenda April 28-30

The CHMP agenda for this month’s meeting (April 28-30) has been released, and it includes two notable items up for CHMP opinion: Invokana/Vokanamet renal protection indication (CREDENCE) and Sanofi’s bs-aspart initial application. Of note, the April 2020 CHMP meeting agenda was just posted today despite the fact that the meeting started yesterday. Below, FENIX provides diabetes-related highlights and insights from the April 2020 CHMP agenda.

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