Tag Archives: Dapagliflozin

Viatris’s Generic Dapagliflozin and Lilly’s Trulicity Pediatric Extension Receive Positive CHMP opinions; Medtronic’s Wearable Partner Files for Bankruptcy; Nemaura Looks to Raise Additional Capital

Four cardiometablic-related news items have been observed: Viatris’s generic dapagliflozin received a positive CHMP opinion for the treatment of T2DM, HF, and CKD (view opinion); Lilly’s Trulicity received a positive CHMP opinion for a label extension to include patients ages 10 years and older (view opinion); Medtronic’s wearable partner, Rockley Photonics Holdings Limited, has filed for bankruptcy (view Form 8-K); Nemaura announced it has entered into a definitive agreement of ~$8.4M registered direct offering and concurrent private placement with two healthcare-focused US institutional investors (view press release). Below, FENIX provides highlights and insights including thoughts on an acquisition opportunity for Medtronic.

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Madrigal Wins Big with Ph3 NASH Data; Novo Expands Partnership for Dose Check; AZ Announces DELIVER Positive CHMP Opinion

Three cardiometabolic-related news items have been observed: Madrigal Pharmaceuticals announced positive topline results from its Ph3 resmetirom MAESTRO-NASH study and hosted an investor call, although the company provided conflicting guidance on the filing timeline (view press release; webcast); Amalgam Rx announced the expansion of its global agreement with Novo Nordisk for the commercialization of Dose Check (view press release); and AstraZeneca announced Forxiga (dapagliflozin) received a positive CHMP opinion for DELIVER (view press release). Below, FENIX provides insights on the respective news items, including readthrough from the Madrigal data to other NASH players.

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Bayer Initiates Kerendia and Jardiance Combo Trial Following Kerendia EU Approval

Bayer announced the initiation of CONFIDENCE, a Ph2 study evaluating the combination therapy of Kerendia (finerenone) and Jardiance (empagliflozin) in patients with CKD and T2DM (view CT.gov record). The trial initiation follows the recent EU approval of finerenone for CKD associated with T2DM in adults (view press release). Recall, finerenone was approved in the US in July 2021 (previous FENIX insight) and is currently under review in China and multiple other countries worldwide. Below, FENIX provides insights into the new CONFIDENCE trial, including thoughts on Bayer’s strategy to do the Ph2 trial with empa instead of dapa.

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Farxiga DAPA-CKD Receives Priority Review from FDA

AstraZeneca announced FDA granted Priority Review to Farxiga for the treatment of chronic kidney disease in patients with and without T2DM based on results from the DAPA-CKD study. Recall, FDA previously granted Breakthrough Therapy designation to Farxiga for CKD in October 2020 following positive results from the DAPA-CKD trial which were first presented at ESC 2020. Of note, AZ stated the PDUFA date will occur in Q2 ’21. Below, FENIX provides a projected approval timeline for the impending DAPA-CKD regulatory review as well as readthrough to the SGLT2i class.

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New AZD9977 + Dapa Ph2b Trial in HF+CKD (MIRACLE)

A CT.gov record has been observed for a new Ph2b trial evaluating AZD9977, a novel mineralocorticoid receptor modulator (MCR), as add-on to dapagliflozin in patients with HF and CKD. The trial initiation is in-line with AZ’s commentary from its Q2 ’20 earnings call (previous FENIX insight). Of note, John McMurray is the PI for the MIRACLE trial. McMurray previously served as the PI for DAPA-HF and a member of the executive committee for DAPA-CKD. Below, FENIX provides an overview of the MIRACLE trial as well as why AZ’s pursuit of accelerated approval for AZD9977 could make sense.

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AZ Provides Additional DAPA-CKD Commentary During Post-Results Investor Call

Following the DAPA-CKD results, which were presented at ESC 2020 on August 30 (previous FENIX insight), AZ hosted a call with investors (view slides here). Beyond reviewing the DAPA-CKD results, AZ senior management and DAPA-CKD investigators provided commentary on the trial results and the new Farxiga market potential. Below, FENIX provides highlights from the investor call as well as additional perspective on the impact of DAPA-CKD.

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DAPA-CKD Results Highly Positive; AZ Winning in SGLT2i LCM

Full results from the DAPA-CKD renal outcomes trial were presented at the 2020 virtual ESC conference (view AstraZeneca press release), but it does not appear the results have been published. Results demonstrated a highly impressive 39% RRR in the primary composite endpoint (sustained ≥50% decline in eGFR, ESKD, renal death, or CV death). Curiously, the CV death component of the primary endpoint failed to demonstrate a statistically significant benefit (HR=0.81; p=0.20); however, there was a statistically significant 31% RRR in all-cause mortality. Below, FENIX provides thoughts on the DAPA-CKD results in the context of the Invokana CREDENCE study (DKD), the ongoing EMPA-KIDNEY trial from BI/Lilly, and Lexicon’s SOLOIST and SCORED CVOTs.

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EMPEROR-Reduced Similarly Positive to DAPA-HF

Full results from the EMPEROR-Reduced HF CVOT were presented at the 2020 virtual ESC conference (view BI/Lilly press release) and published in the NEJM (view publication). Results demonstrated a 25% RRR in the primary composite endpoint (hospitalization for heart failure or CV death), which is consistent with the 26% RRR observed in AZ’s DAPA-HF. Below, FENIX provides thoughts on the EMPEROR-Reduced results in the context of DAPA-HF and the evolving HF landscape.

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AZ CVRM Q1 ’20 Earnings Update

AstraZeneca hosted its Q1 ’20 earnings call and briefly discussed its diabetes business including the recent topline data readout from DAPA-CKD, which stopped early for overwhelming efficacy. Interestingly, AZ said it does not project DAPA-CKD filing acceptance until 2021. Below, FENIX provides highlights and insights from the call, including thoughts on why the DAPA-CKD submission is later than expected.

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