Tag Archives: astrazeneca

AZ’s Qtrilmet Triple-combo Receives EC Approval; New Data from Fractyl, Dario, and Valeritas

Today, a series of diabetes-related news has been observed including the EC approval of AZ’s Qtrilmet (dapa+saxa+met triple FDC)as well as new data from Fractyl, Dario, and Valeritas related to the concurrent Diabetes Technology Meeting occurring in Bethesda. Below, FENIX provides highlights and insights on the respective news items.

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AstraZeneca Q3 ’19 Earnings Update

AZ hosted its Q3 ’19 earnings call (press release) and provided updates to their diabetes commercial, clinical, and regulatory activities. Importantly, AZ highlighted the DECLARE US and EU approvals as well as continued HF and CKD LCM for Farxiga. Below, FENIX provides diabetes-related highlights and insights from the call.

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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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AZ’s Triple FDC (Dapa/Saxa/Met) Receives Positive CHMP Opinion

AstraZeneca announced it received a positive CHMP opinion for the FDC of dapagliflozin+saxagliptin+metformin branded as “Qtrilmet.” Recall, FDA approved AZ’s triple FDC (called Qternmet XR in the US) in May 2019. Below, FENIX provides brief thoughts on the Qtrilmet positive CHMP opinion.

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More Thoughts from DAPA-HF… Could Novo+Lexicon Really Happen?

With the historic results of DAPA-HF recently presented at ESC 2019, FENIX provided some initial reaction. Today, FENIX continues to think about additional market possibilities and implications inside and outside SGLT2i dynamics in a winners-and-losers analysis format.

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DAPA-HF is a Home Run, But Results Remain Unpublished

Full results from AstraZeneca’s Farxiga DAPA-HF trial were presented at ESC 2019. Data from the trial showed an impressive 26% RRR (p<0.0001) in the primary composite endpoint (CV death or worsening of heart failure) with both components contributing to the highly statistically significant result. Additionally, Novartis presented results from the Entresto PARAGON-HF trial (patients with HFpEF) which narrowly missed statistical significance on the primary endpoint but showed benefit in key subpopulations. Of note, it appears that DAPA-HF has not yet been published in any scientific journal, and the p-value in the AZ press release did not exactly match what was presented during ESC 2019. Below, FENIX provides thoughts on the DAPA-HF and PARAGON-HF results in the context of the evolving HF market.

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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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