Tag Archives: Dapagliflozin

DAPA-HF is a Home Run, But Results Remain Unpublished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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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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Dapa T1DM CRL Received by AZ

Today, AZ announced it received a CRL from FDA for the Farxiga T1DM label expansion. The news comes on the heels of the July 12 NICE recommendation for Forxiga T1DM reimbursement in the UK. Below, FENIX provides thoughts on what the AZ CRL could mean for the SGLTi class in T1DM, including read-through to BI/Lilly and Lexicon/Sanofi.

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Farxiga DECLARE Positive CHMP Opinion

AstraZeneca announced it received a positive CHMP opinion for the DECLARE CVOT. AZ is anticipated to comment on the US and EU DECLARE regulatory activities during its upcoming Q2 ’19 earnings call on July 25. Below, FENIX provides brief thoughts on the impending EMA approval in the context of the ongoing FDA review.

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