Category Archives: Topics

Daprodustat FDA Adcom Scheduled for October 26, 2022

FDA has requested an advisory committee on October 26, 2022, to discuss the use of GSK’s daprodustat for the treatment of anemia due to CKD in non-dialysis dependent (NDD) and dialysis-dependent (DD) adults (view FDA document here). Recall, in April 2022, FDA accepted the daprodustat NDA and set a PDUFA date for February 1, 2023, suggesting a standard review of 12 months total for an NME (previous FENIX insight). The NDA was based on positive results from five Ph3 studies in the ASCEND program which were reported in July 2021 (previous FENIX insight). Below, FENIX provides brief thoughts on the dapro adcom in the context of roxadustat and vadadustat.

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Kerendia Label Updated to Include FIGARO-DKD Data

Bayer announced Kerendia received FDA approval for an updated label to include findings from the FIGARO-DKD CVOT (view updated label). Recall, FIGARO demonstrated a 13% RRR in the primary composite endpoint (CV death, non-fatal MI, non-fatal stroke, or hHF) in patients with CKD and T2DM (previous FENIX insight). For context, Kerendia was approved with data from the FIDELIO-DKD trial, a sister study to FIGARO. Below, FENIX provides thoughts on the new Kerendia CKD label extension, including read-through to the SGLT2i class.

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Dexcom Promotes Jake Leach to COO; Biocon Receives More Form 483 Observations; Seraxis Appoints Paul Strumph as CMO; Intarcia ITCA-650 CRL Chronicle Concludes

A series of cardiometabolic-related updates have been observed: Dexcom announced Jake Leach (view LinkedIn) has been promoted to COO; Biocon announced it received more Form 483 observations; Seraxis announced the appointment of Paul Strumph (view LinkedIn) to CMO; and Intarcia Therapeutics received a letter from FDA (view here) denying a hearing for ITCA-650. Below, FENIX provides context and insight on the respective news items.

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Ypsomed Launches Remote Bolus Feature; Lannett Completes Bs-glargine Pivotal Trial; Madrigal Initiates MAESTRO-NASH Outcomes Study for Resmetirom

Three cardiometabolic-related news items have been observed: Ypsomed announced the launch of a smartphone bolus delivery feature for its mylife YpsoPump using the mylife App; Lannett announced it completed subject dosing in its Ph1 bs-glargine pivotal trial (view CT.gov record); and Madrigal announced the initiation of a Ph3 MAESTRO-NASH Outcomes study evaluating the effect of QD oral 80mg resmetirom compared to placebo in patients with compensated NASH cirrhosis (view CT.gov record). Below, FENIX provides context and insight on the respective news items.

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Repatha CVOT OLE Shows Long-term RRR; Poxel Announces Positive Results for PXL065 Ph2 Trial in NASH

Two cardiometabolic-related news items have been observed: Amgen presented Ph3 positive data for Repatha (Evolocumab) in adults with ASCVD at ESC 2022; and Poxel announced positive topline results for the Ph2 DESTINY-1 trial in NASH (view CT.gov record). Below, FENIX provides context and insight on the respective news items.

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Thoughts on SURMOUNT-MMO after SELECT Interim Analysis

At its Q2 ’22 earnings in August, Novo Nordisk disclosed that SELECT, the Wegovy CVOT, would not stop for overwhelming efficacy at a pre-specified interim analysis (previous FENIX insight). With all the hype now passed, the trial design lens turns to Lilly’s tirzepatide obesity CVOT, SURMOUNT-MMO. Below, FENIX provides thoughts on SURMOUNT-MMO, including Lilly’s potential strategy to get a broad metabolic indication, similar to what BI/Lilly did in HF with Jardiance by eliminating LVEF label language.

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Under-DELIVERed: Results Parity for AZ at ESC

Results from AZ’s Ph3 DELIVER (Farxiga HF outcomes trial in HFpEF; press release) and new results from a pre-specified pooled analysis from the Ph3 DAPA-HF and DELIVER trials (press release) were presented at ESC 2022 and simultaneously published in the NEJM (view publication) and Nature Medicine (view publication), respectively. Of note, an 18% RRR was observed in the DELIVER primary composite endpoint (hHF+urgent hospitalization and CV death). Below, FENIX provides highlights, insights, and implications from DELIVER in the context of BI/Lilly’s EMPEROR-Preserved and the evolving CVRM global landscape.

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AZ to Initiate Ph2 Dapa + Zibotentan Trial in Cirrhosis; Esperion’s BA Included in ACC’s ECDP Guidelines

Two cardiometabolic-related news items have been observed: an AZ-sponsored Ph2 dapa + zibotentan combination trial in cirrhosis (ZEAL) has been observed (view CT.gov record); and Esperion announced the ACC’s ECDP guidelines now include bempedoic acid as an oral non-statin therapy to lower LDL-C. Below, FENIX provides context and insight on the respective news items.

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“Mass” Layoff at Beta Bionics?; Novo Initiates Ph3 Ozempic + Lower-Dose Glargine Trial; Novartis to Spin Off Sandoz; Lannett and Adocia CY Q2 ’22 Earnings Updates; Hygieia Appoints New CEO

A series of cardiometabolic-related updates have been observed: Beta Bionics has reportedly laid off an unknown number of employees (view LinkedIn post); a Novo-sponsored Ph3 trial evaluating Ozempic and lower-dose insulin glargine has been observed (SUSTAIN OPTIMIZE; view CT.gov record); Novartis announced plans to spin off Sandoz (press release); Lannett (press release) and Adocia (press release) released their Q2 ’22 earnings; and Hygieia announced the appointment of a new CEO. Below, FENIX provides context and insight on the respective news items.

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Medtronic CY Q2 ‘22 Earnings Updates; Glytec Collaborates with CPS for Glycemic Management Technology

Two cardiometabolic-related news items have been observed: Medtronic (press release; slides) released their CY Q2 ‘22 (FY Q1 ‘23) earnings, including updates to the ongoing FDA warning letter situation; and Glytec announced a partnership with CPS to offer glycemic management technology to HCPs (press release). Below, FENIX provides context and insight on the respective news items.

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