Bayer to present data from cardiovascular portfolio

Friday, Sep 03, 2021 14:00

Bayer presented new cardiovascular data across its approved and investigational treatments at the 2021 ESC Congress held from August 27 to 30.

Three late breaking abstracts presented included detailed results for the investigational, non-steroidal, selective mineralocorticoid receptor (MR) antagonist and the Factor Xa inhibitor, data that highlighted its ongoing commitment to improving the lives of patients with kidney and cardiovascular diseases, the company said.

Following a topline presentation at the ESC Heart Failure Congress in June, it also presented the latest European Society of Cardiology and Heart Failure Association Guidelines on Acute and Chronic Heart Failure at the ESC Congress and has made it available for use.

Bayer is an innovation leader in the area of cardiovascular diseases.

The update explicitly has recognised worsening heart failure for the first time.

The guidelines recommend only one treatment for a worsening heart failure event on top of foundational, recommended heart failure therapies: Bayer’s soluble guanylate cyclase stimulator (sGC).

At the congress, Bayer presented detailed results from the FIGARO-DKD study.

The topline results of Bayer’s Phase III study FIGARO-DKD evaluating the efficacy and safety of the investigational drug non-steroidal, selective mineralocorticoid receptor antagonist (MRA) versus placebo, when added to standard of care in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D), were shared in May.

The study met its primary endpoint, showing that this solution significantly reduces the composite risk of time to first occurrence of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or hospitalisation for heart failure.

Together with FIGARO-DKD, Bayer has also presented new findings from FIDELITY, the integrated analysis of both FIDELIO-DKD and FIGARO-DKD.

The aim of FIDELITY was to evaluate the efficacy and safety of non-steroidal, selective mineralocorticoid receptor antagonist across the spectrum of patients with chronic kidney disease (CKD) in type 2 diabetes (T2D).

The detailed results from the FIGARO-DKD study and data from the FIDELITY analysis was presented at the live-streamed, late-breaking clinical trial session.

Non-vitamin K antagonist oral anti-coagulant (NOAC) study data:

New late-breaking non-vitamin K antagonist oral anti-coagulant (NOAC) VOYAGER PAD study data has evaluated sex-based outcomes in patients with symptomatic peripheral artery disease (PAD) post-revascularisation and the ANTENNA, EMIR, and AFIRE studies in patients with atrial fibrillation.

Soluble guanylate cyclase (sGC) stimulator VICTORIA study data:

New data from the Phase III VICTORIA trial was presented at the congress. Three abstracts has provided further insights into the use of soluble guanylate cyclase (sGC) stimulator in patients with symptomatic chronic heart failure, including those receiving an angiotensin receptor neprilysin inhibitor.

About non-steroidal, selective mineralocorticoid receptor antagonist (MRA)

Non-steroidal, selective mineralocorticoid receptor antagonist (MRA) is an investigational, non-steroidal, selective antagonist of the mineralocorticoid receptor that in pre-clinical studies has been shown to block the harmful effects of mineralocorticoid receptor overactivation.

Bayer said it recently announced the initiation of the FINEARTS-HF study, a multi-centre, randomised, double-blind, placebo-controlled phase III study to investigate non-steroidal, selective mineralocorticoid receptor antagonist (MRA) compared to placebo in more than 5,500 symptomatic heart failure patients with a left ventricular ejection fraction of 40 per cent onwards.

About non-vitamin K antagonist oral anti-coagulant (NOAC) of Bayer

Non-vitamin K antagonist oral anti-coagulant (NOAC) is the most broadly indicated therapy worldwide. This therapy is approved for more venous and arterial thromboembolic (VAT) conditions than any other NOAC:

• The prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) with one or more risk factors

• The treatment of pulmonary embolism (PE) in adults

• The treatment of deep vein thrombosis (DVT) in adults

• The prevention of recurrent PE and/or DVT in adults

• The prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip replacement surgery

• The prevention of VTE in adult patients undergoing elective knee replacement surgery

• The prevention of atherothrombotic events after an Acute Coronary Syndrome in adult patients with elevated cardiac biomarkers when co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine

• The prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk for ischaemic events when co-administered with acetylsalicylic acid (ASA)

• Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years after at least 5 days of initial parenteral anticoagulation treatment

Non-vitamin K antagonist oral anti-coagulant (NOAC) of Bayer is approved in more than 130 countries, although the approved labelling, including the number of indications, may differ from country to country. Since launch in 2008, more than 86 million patients have been treated.

Bayer is an innovation leader in the area of cardiovascular diseases, with a long commitment to delivering science for a better life by advancing a portfolio of innovative treatments.

The heart and the kidneys are closely linked to health and disease, and Bayer is working in a wide range of therapeutic areas on new treatment approaches for cardiovascular and kidney diseases with high unmet medical needs.

The cardiology franchise at Bayer already includes a number of products and several other compounds in various stages of pre-clinical and clinical development.

They reflect the company’s approach to research, which prioritises targets and pathways with the potential to impact the way that cardiovascular diseases are treated.

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