Tag Archives: SGLT2i

Empa T1DM FDA Adcom Overwhelmingly Negative (2-14); Is SGLTi in T1DM Approvable in the US?

Today, FDA held an advisory committee meeting to discuss the benefit/risk profile of 2.5mg empagliflozin for the treatment of T1DM. Somewhat surprisingly, the panel voted overwhelmingly against (2-14) the approval of 2.5mg empa based on the currently characterized benefit/risk profile and small amount of supporting data. BI/Lilly subsequently issued a press release regarding the outcome of the adcom. Below, FENIX provides insight into the future of SGLTi therapy in T1DM including implications to BI/Lilly, AZ, and Lexicon.

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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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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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DAPA-HF is a Home Run, But Results Remain Unpublished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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J&J Q2 ’19 Earnings Update

Johnson & Johnson hosted their Q2 ’19 earnings call and briefly discussed the Invokana franchise. Of note, management did not comment on the recent decision to return JNJ-64565111 rights back to Hanmi. Below, FENIX provides highlights and diabetes-related insights from the call.

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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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