Group 3 Pulmonary Hypertension: From Bench to Bedside

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Lilly Cuts Mid-stage Relaxin Study In Chronic Kidney Disease For 'Lack Of Foreseeable Clinical Benefit'

Eli Lilly last week terminated a Phase II trial of its investigational relaxin analog volenrelaxin in chronic kidney disease, according to an update to the study's clinicaltrials.Gov webpage.

Lilly is dropping the study because of "a lack of foreseeable clinical benefit" in its target chronic kidney disease (CKD) population. The termination notice also referenced a similarly discontinued "related heart failure study that demonstrated no benefit in an overlapping patient group." It remains unclear what cardiovascular study this is, though another Phase II trial of the candidate in chronic heart failure with preserved ejection fraction remains tagged as active but is not recruiting.

BioSpace has reached out to Eli Lilly for clarification and will update this space as appropriate.

Volenrelaxin is a synthetic analog of the human relaxin protein that activates the relaxin receptor. Animal studies of the molecule showed that volenrelaxin can elicit relaxin-related pharmacological response, including greater renal blood flow in rats.

A Phase I trial found volenrelaxin to be safe and suitable for subcutaneous dosing, and identified promising signals of efficacy. The synthetic hormone resulted in "sustained improvement in kidney perfusion upon repeated dosing," according to the study, supporting its further clinical development in chronic kidney disease and chronic heart failure.

Lilly is scheduled to hold its fourth-quarter and full-year earnings call on Feb. 6.

The pharma's decision to cut volenrelaxin's mid-stage CKD study has also affected Massachusetts-based Tectonic Therapeutics, whose stock price tanked as much as 40% on Tuesday after the news broke.

Tectonic is advancing TX45, a relaxin fusion molecule that activates the RXFP1 receptor, not unlike volenrelaxin. The biotech is proposing TX45 as a treatment for pulmonary hypertension in the presence of heart failure with preserved ejection fraction.

In a flash note on Tuesday, analysts at Leerink Partners noted that Lilly's decision to terminate the volenrelaxin study "has caused significant concern about the likelihood of success of TX45." In a separate follow-up note, however, the Leerink analysts reiterated their confidence in Tectonic, pointing to several key differences between TX45 and volenrelaxin.

TX45, for instance, uses a different relaxin approach than Lilly's candidate, and is being tested for different indications, according to the Leerink note. Tectonic is also targeting distinct endpoints from Lilly. Tectonic is building toward a Phase Ib readout in the first quarter of 2025.

Congestive Heart Failure Treatment Market Predicted Growth At 4.47% CAGR To 35.5 Billion USD By 2032 Gilead Sciences

(MENAFN- EIN Presswire)

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The Global Congestive Heart Failure Treatment market is witnessing significant growth due to several key drivers. An aging global population

US, NY, UNITED STATES, January 29, 2025 /EINPresswire / -- Congestive Heart Failure Treatment Market industry Overview 2025 By Treatment Type (Medication, Surgery, Device Therapy, Lifestyle Changes), By Drug Class (Angiotensin-Converting Enzyme Inhibitors, Beta-Blockers, Diuretics, ARNI, Aldosterone Antagonists), By Patient Type (Newly Diagnosed, Chronic Patients, pediatric Patients), By Route of Administration (Oral, Intravenous, Subcutaneous) and By Regional (North America, Europe, South America, Asia Pacific, Middle East and Africa) - Industry Growth Forecast to 2032

Congestive Heart Failure Treatment Market Overview

Rising prevalence of cardiovascular diseases propels market growth.

Congestive Heart Failure Treatment Market growth was valued at 23.94 Billion USD in 2023. Congestive Heart Failure Treatment Market Industry is expected to grow from 25.01 Billion USD in 2024 to 35.5 Billion USD by 2032. Congestive Heart Failure Treatment Market share is projected at a CAGR 4.47% during forecast period 2025 - 2032. Personalized heart failure management and AI-enabled diagnostic tools set new benchmarks.

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Merck

Roche

Gilead Sciences

Pfizer

BristolMyers Squibb

Novartis

Biogen

Cardiorentis

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Johnson and Johnson

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Amgen

Eli Lilly

Sanofi

AstraZeneca

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The future of healthcare is shaped by emerging technologies such as AI, robotics, and biotechnology. AI is enhancing diagnostics, decision-making, and operational efficiency, while robotics is transforming surgeries, rehabilitation, and elder care. Breakthroughs in CRISPR, gene therapy, and regenerative medicine promise new frontiers in treatment. Quantum computing holds potential for advancing drug discovery and managing complex data.

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Congestive Heart Failure Treatment Market Treatment Type Outlook

Medication

Surgery

Device Therapy

Lifestyle Changes

Congestive Heart Failure Treatment Market Drug Class Outlook

Angiotensin-Converting Enzyme Inhibitors

Beta-Blockers

Diuretics

ARNI

Aldosterone Antagonists

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Newly Diagnosed

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Pediatric Patients

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Oral

Intravenous

Subcutaneous

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North America

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Furthermore, the report evaluates the crucial market trends, drivers, and influencing factors that shape the global outlook for Congestive Heart Failure Treatment Market. An aging global population is increasing the demand for geriatric and long-term care, especially in developed nations. Healthcare systems are adapting by developing specialized services and infrastructure to address age-related diseases such as Alzheimer's. Concurrently, the world faces various health challenges, including infectious diseases like pandemics and antimicrobial resistance (AMR), non-communicable diseases (NCDs) such as diabetes and heart disease, and a rising focus on mental health as an essential component of overall well-being.

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healthcare strategies, encouraging collaborative approaches to improve population health.

The industry is also investing in advanced training and workforce development, equipping healthcare professionals to adapt to new technologies and interdisciplinary care models. However, challenges such as safeguarding data privacy and security, balancing innovation with affordability, addressing workforce shortages, and navigating ethical concerns related to AI, genetic engineering, and end-of-life care remain significant hurdles for the future. The healthcare industry's evolution is set to prioritize innovation, inclusivity, and sustainability, ensuring better health outcomes globally.

By triangulating data from multiple sources, this approach helps validate findings and generate new insights. The analysis encompasses the assessment of research design, data collection techniques, sampling methods, and data analysis tools utilized in the study. By examining these elements, the analysis aims to determine the reliability, validity, and generalizability of the research findings.

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FDA Approves Novo Nordisk's Ozempic To Reduce Kidney Disease In Patients With Type 2 Diabetes, Chronic Kidney Disease

Approval was based on results from the Phase IIIb FLOW trial, which demonstrated a 24% relative risk reduction in kidney disease, kidney failure, and cardiovascular death in patients treated with Ozempic.

Image Credit: Adobe Stock Images/arti om

The FDA has approved Novo Nordisk's Ozempic (semaglutide) as the first and only GLP-1 receptor agonist (GLP-1 RA) indicated to reduce the risk of worsening kidney disease, kidney failure, and cardiovascular death in adults with type 2 diabetes and chronic kidney disease (CKD). According to the company, approval was based on data from the Phase IIIb FLOW trial, which demonstrated a significant risk reduction in all three indications compared to placebo.1

"[CKD] is very serious and common in patients living with type 2 diabetes and represents a critical need for adults living with these comorbidities. This approval for Ozempic allows us to more broadly address conditions within cardiovascular-kidney-metabolic syndrome, which affects millions of adults and could have serious consequences if left untreated," said Anna Windle, PhD, SVP, clinical development, medical & regulatory affairs, Novo Nordisk, in a press release. "With this new indication, Ozempic stands out uniquely as the most broadly indicated GLP-1 RA in its class. We are proud to continue advancing innovations that will have a meaningful impact for this patient population, underscoring Novo Nordisk's commitment to cardiometabolic care."

The international, randomized, double-blind, parallel-group, placebo-controlled, event-driven FLOW superiority trial that compared 1 mg of weekly Ozempic with placebo. The trial was conducted at an estimated 400 sites across 28 countries, with 1,767 adults enrolled in the Ozempic group and 1,766 enrolled in the placebo group. The trial's primary endpoint was a statistically significant and superior risk reduction compared to placebo in the worsening of kidney disease, kidney failure, and cardiovascular disease-related deaths, in addition to standard-of-care.

Results found that Ozempic provided a 24% relative risk reduction in all three outcomes compared to placebo.1

Serious adverse events (AEs) were less common in the Ozempic group compared to the placebo group. Serious AEs included diabetic retinopathy; COVID-19; cardiovascular disorder; heart failure; acute kidney failure; malignant tumor; and serious gastrointestinal disorder.2 Novo Nordisk warns against the use of Ozempic in patients who have a family history of medullary thyroid carcinoma, multiple endocrine neoplasia syndrome, or are allergic to any of the treatment's ingredients.1

According to the company, CKD affects approximately 37 million adults in the United States, with the expectation that these numbers will continue to rise as a result of an increased aging population. Current data indicated that 40% of patients with type 2 diabetes also live with CKD.1

"Type 2 diabetes can be challenging enough to manage without the added risk of chronic kidney disease, and I have seen in my own practice that patients with type 2 diabetes and chronic kidney disease need extra support from medications that may have a profound clinical impact by lowering the risk of major kidney and cardiovascular outcomes," said Richard E. Pratley, MD, medical director, Advent Health Diabetes Institute Orlando, FL, co-chair, FLOW Trial, in the press release. "A large portion of patients I treat experience serious kidney complications and comorbidities, with some even requiring dialysis. Today's decision by the FDA offers hope for the millions of adults living with both conditions and provides an additional treatment option, representing a significant advancement for my patients."

First approved in 2017 to improve blood sugar in combination with diet and exercise, Ozempic is also indicated to reduce the risk of heart attack, stroke, or death in adults with type 2 diabetes with known heart disease.1

References

1. FDA approves Ozempic® (semaglutide) as the only GLP-1 RA to reduce the risk of worsening kidney disease and cardiovascular death in adults with type 2 diabetes and chronic kidney disease. PR Newswire. January 28, 2025. Accessed January 29, 2025. Https://www.Prnewswire.Com/news-releases/fda-approves-ozempic-semaglutide-as-the-only-glp-1-ra-to-reduce-the-risk-of-worsening-kidney-disease-and-cardiovascular-death-in-adults-with-type-2-diabetes-and-chronic-kidney-disease-302362466.Html

2. Ozempic® (semaglutide) injection 1 mg demonstrated reduction in risk of kidney disease-related events in Phase 3 FLOW trial presented at the 84th Scientific Sessions of the American Diabetes Association. Novo Nordisk. June 24, 2024. Accessed January 29, 2025. Https://www.Novonordisk-us.Com/media/news-archive/news-details.Html?Id=168527

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