Tag Archives: astrazeneca

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.

This content is for Read Less members only.
Register
Already a member? Log in here

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.

This content is for Read Less members only.
Register
Already a member? Log in here

DELIVER Filed in US? August 2022 CHMP Agenda

The CHMP agenda for this month’s meeting (August 16-19) has been released and includes several cardiometabolic-related agenda items. Of note, the August CHMP meeting only has written procedures, not oral explanations. Notably, AZ’s Forxiga (dapagliflozin) has been filed for an indication extension based on the DELIVER HFpEF trial results. Below, FENIX provides highlights from the August 2022 CHMP agenda.

This content is for Read Less members only.
Register
Already a member? Log in here

Novo’s QW Insulin Icodec Meets Primary Endpoints in ONWARDS 3 and 4; AZ and Alnylam Q2 ’22 earnings updates; Better Therapeutics Meets Secondary Endpoint in BT-001 Pivotal Trial in T2DM

A series of cardiometabolic-related news items have been observed: Novo announced topline results from the QW insulin icodec Ph3 ONWARDS 3 and ONWARDS 4 trials in T2DM; AZ (press release; slides) and Alnylam (press release; slides) hosted their respective earnings calls; and Better Therapeutics (BT) announced positive secondary endpoint results for its BT-001 pivotal clinical trial in T2DM and held an associated investor call (view webcast). Below, FENIX provides highlights and insights for the respective new items.

This content is for Read Less members only.
Register
Already a member? Log in here

DELIVER Delivers for AZ; Priority Review Depends on CV Death

AstraZeneca announced top-line results from the Ph3 DELIVER trial (view CT.gov record) demonstrating AZ’s Farxiga (dapagliflozin) has met the primary composite endpoint of CV death or worsening HF in HFpEF subjects. Below, FENIX provides initial thoughts.

This content is for Read Less members only.
Register
Already a member? Log in here

New Medtronic 780G + Lyumjev Trial; Xigduo XR DAPA-CKD sNDA approved; Galectin NASH Trial to Continue; Sciwind Initiates Ph1 Oral GLP-1RA Trial

A series of cardiometabolic-related news items have been observed: a Medtronic-sponsored study evaluating the use of Lilly’s Lyumjev in the MiniMed 780G AID system has been observed (view CT.gov record); the Xigduo XR (dapagliflozin + metformin) DAPA-CKD sNDA has recently been approved (view updated label); Galectin Therapeutics reported positive feedback from its first DSMB meeting for its Ph2b/3 NAVIGATE study evaluating belapectin in NASH (press release); and Sciwind Biosciences announced it has started dosing patients in its Ph1 MAD study evaluating the company’s investigational oral GLP-1RA (XW004; ecnoglutide) in healthy volunteers. Below, FENIX provides highlights and insights for the respective new items.

This content is for Read Less members only.
Register
Already a member? Log in here

Will AZ Fund an Additional Roxa Trial?; Senseonics Eversense E3 CGM Receives FDA Approval

Two cardiometabolic-related news items have been observed: AZ’s Executive VP and head of biopharmaceuticals R&D conducted an interview and commented on the likelihood of performing another roxadustat trial to address the FDA CRL (view article); and Senseonics announced its Eversense E3 CGM (180-day sensor) has received FDA approval. Below, FENIX provides highlights and insights for the respective new items.

This content is for Read Less members only.
Register
Already a member? Log in here

AZ Q4 ’21 and FY ’21 Earnings Update

AstraZeneca hosted its Q4 ’21 earnings call (press release; slides). Much of the prepared remarks and Q&A focused on the company’s COVID-19 vaccine development, recent Alexion acquisition, and oncology portfolio. The cardiometabolic-related discussion primarily highlighted AZ’s pipeline initiatives in HF and CKD. Of note, AZ did not provide any commentary regarding Roxadustat during the call; however, FENIX will be covering the upcoming FibroGen earnings call anticipated to be held on March 1, 2022. Key points from the AZ Q4 ’21 earnings call are listed below.

This content is for Read Less members only.
Register
Already a member? Log in here