Category Archives: Topics

Fiasp Approved for Pump Use in US

Novo Nordisk announced FDA approved Fiasp pump compatibility in adults with T1DM and T2DM. According to Novo, the updated label is based on data from the Onset 5 clinical trial (CT.gov record). Recall, Onset 5 demonstrated non inferiority in the primary outcome measure of change in A1C, but failed to show superiority. Below, FENIX provides context and insight surrounding the approval, including read-through to Lilly’s ultra rapid-acting insulin lispro (URLi).

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Thoughts on DECLARE FDA Approval

AstraZeneca announced FDA approved a Farxiga heart failure indication in T2DM patients based on results from the DECLARE CVOT. Below, FENIX provides a DECLARE label analysis as well as potential market implications to the SGLT2i class particularly ahead of the DAPA-HF FDA filing/approval.

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Abbott Acknowledges Libre 2 Delay; Abbott and Roche Q3 ’19 Earnings Updates

Abbott and Roche hosted their respective Q3 ’19 earnings calls and provided updates to their diabetes businesses. Of note, Abbott confirmed that Libre 2 US approval is delayed from initial expectations, and Abbott indicated they are working through several items with FDA. Below, FENIX provides highlights and insights from the respective calls.

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Abbott and Tandem partnership; Livongo partners with VSP Vision Care

Abbott and Tandem Diabetes Care announced plans to develop an integrated diabetes solution utilizing Abbott’s glucose monitoring sensors (Libre) and Tandem’s insulin delivery systems. Additionally, Livongo and VSP Vision Care announced a partnership to expand eye care outreach efforts to Livongo members with diabetes. Below, FENIX provides context and broader implications on these partnerships.

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J&J Q3 ’19 Earnings Update

Johnson & Johnson hosted their Q3 ’19 earnings call (press release) and briefly discussed the Invokana franchise. Of note, J&J only briefly mentioned the recent Invokana DKD approval based on results from the CREDENCE trial. Below, FENIX provides highlights and diabetes-related insights from the call.

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Abbott Partners with Omada; New Senseonics BCBS Coverage; Adocia Receives €15M in Funding; Roche Partners with iHeartMedia

Today, three major news items were observed covering a new partnership between Abbott and Omada Health, Senseonics Eversense new BCBS coverage decision, €15 million in financing for Adocia, and a Roche/iHeartMedia diabetes awareness concert. Below, FENIX provides thoughts and analysis for each respective news item.

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Lilly Nasal Glucagon CHMP Opinion This Week (CHMP Agenda October 14-17)

The CHMP agenda for this week’s meeting (October 14-17) has been released, and it includes two notable items (Lilly nasal glucagon opinion and Toujeo age indication extension). Below, FENIX provides diabetes-related highlights and insights from the CHMP agenda.

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Abbott Libre 2 US Approval Conspicuously Late?

The FDA approval of Abbott’s next-generation CGM, Libre 2, appears to be conspicuously late, which has created questions as to what the potential issue could be. Below, FENIX provides evidence and hypotheses surrounding the delayed Libre 2 US approval. See the full blast for more details on our 3 hypotheses.

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Jardiance T1DM Adcom Scheduled for Nov 13

FDA has requested an advisory committee on November 13, 2019 to discuss the use of empagliflozin in T1DM. Of note, the empa T1DM adcom appears to be part of a 2-day adcom with Amarin’s REDUCE-IT which is scheduled for November 14. As always, FENIX will provide full coverage and analysis of the adcom. Below, FENIX provides brief thoughts on the empa T1DM adcom including hypotheses as to why the empa T1DM review has progressed to an adcom while Lexicon and AZ received CRLs for sota and dapa, respectively.

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