Category Archives: SGLT2i

DAPA-HF @ ESC 2019 on Sunday Sept 1

AstraZeneca announced that the Farxiga DAPA-HF study will be presented on Sunday, September 1, 2019 the European Society of Cardiology (ESC) congress in Paris. Of note, DAPA-HF will be presented during the same session as THEMIS (Brilinta in patients with established CAD and T2DM) and PARAGON-HF (Entresto in patients with HFpEF). On August 20, AZ announced positive topline results from the trial. FENIX will be providing an in-depth analysis of the data following the ESC presentation.

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AZ’s Farxiga CKD Development Receives Fast Track Designation

AstraZeneca announced FDA granted Fast Track designation to Farxiga for the prevention of renal failure and CV/renal death in patients with CKD. Recall, AZ recently announced positive topline results for DAPA-HF and subsequently purchased a priority review voucher (PRV) which FENIX believes could be used for the Farxiga HF filing. Below, FENIX provides thoughts on the Farxiga Fast Track designation in the context of Janssen’s CREDENCE FDA filing which received FDA priority review.

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Thoughts on AZ PRV Purchase and Potential Uses

AstraZeneca announced it purchased a priority review voucher (PRV) for $95M from Sobi, a subsidiary of Swedish Orphan Biovitrum AB. Below, FENIX provides thoughts on the PRV including potential scenarios for which AZ could use the PRV for either Farxiga (DAPA-HF), roxadustat (CKD anemia), or for part of its oncology franchise (trastuzumab deruxtecan), and why AZ is unlikely to use the PRV for the Epanova STRENGTH CVOT.

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Farxiga Positive Topline DAPA-HF Results

AstraZeneca announced positive topline results from the DAPA-HF trial which evaluated the effect of dapagliflozin on the composite of CV death or worsening heart failure (HF). AZ did not provide any details (e.g. hazard ratios) for DAPA-HF; however, the company is likely looking to present the trial at the 2019 AHA conference (November 16-18). Below, FENIX provides insight into the positive DAPA-HF results including potential readthrough to BI/Lilly, Janssen, and Lexicon.

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New Jardiance TV DTC Campaign Observed

A new Jardiance TV DTC commercial, called “Audrey is on it,” has been observed. Of note, the commercial is set to the tune of the 1981 hit “Apache (Jump on it)” by the Sugarhill Gang, potentially in response to the success of other T2DM commercials that have also used jingles (Ozempic, Farxiga, and Tresiba). Below, FENIX provides analysis of the Jardiance TV commercial including insight on how the commercial’s football/marching band theme is apropos leading into the NFL and college football seasons.

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Merck Q2 ’19 Earnings Update

Merck hosted its Q2 ’19 earnings call but did not provide any updates to its diabetes business beyond the Januvia and Steglatro financial performances. Unsurprisingly, the vast majority of the discussion was focused on Merck’s oncology and HIV portfolios. Below, FENIX provides diabetes-related highlights from the call.

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Empa T1DM Filed with FDA; Oral GLP-1RA Advanced to Ph1; Lilly Q2 ’19 Earnings Update

Lilly hosted its Q2 ’19 earnings call and provided updates across its diabetes business. Of note, Lilly’s pipeline now lists empa T1DM as being filed (FDA refused to accept the initial sNDA). Following the 36-week results from Lilly’s AWARD-11 study, Lilly said it plans to file high-dose Trulicity with regulatory authorities “by late 2019.” Furthermore, Lilly’s oral GLP-1RA, called “GLP-1 NPA” (GLP-1 non-peptide agonist), has advanced to Ph1. Below, FENIX provides diabetes-related highlights and insights from the call, including the assumption that the REWIND CHMP agenda listing for July was only for adoption of supplementary information.

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