Search Results for “cardiovascular” – Page 29 – media

Alnylam’s RNA interference drug wins favour of FDA AdCom

The US Food and Drug Administration (FDA) voted nine to three in favour of expanding the label of Alnylam Pharmaceuticals’ Onpattro (Patisiran) at a 13 September Advisory Committee (AdCom) meeting. A possible approval would allow the drug to be used to treat cardiomyopathy caused by a wild-type or hereditary transthyretin-mediated amyloidosis (ATTR/ ATTR-CM). At a Cardiovascular and Renal Drugs AdCom meeting, a panel reviewed results from the Phase III (NCT03997383) APOLLO-B trial. In the study, the drug showed favourable effects on functional capacity and quality of life. The drug also demonstrated a good safety profile through the 18 months of treatment with most adverse events being mild or moderate, as per May 2023 interim results. The AdCom discussed if the results from the APOLLO-B study were enough to prove a clinically meaningful benefit for the drug in the new indication. Dr Eric Peterson, a professor of internal medicine at the ...
- Source: drugdu
- 185
- September 16, 2023
Alnylam Wins Adcomm’s Support for Heart Disease Drug Despite FDA Concerns

By Hayley Shasteen Pictured: FDA headquarters, iStock, GrandbrothersT he FDA’s Cardiovascular and Renal Drugs Advisory Committee on Wednesday voted 9-3 in favor of Alnylam Pharmaceuticals’ patisiran on whether its benefits outweigh its risks for the treatment of adults with cardiomyopathy induced by transthyretin amyloidosis. In the company’s announcement on Wednesday, Alnylam CMO Pushkal Garg said the “positive outcome” of the adcomm meeting is “supported by the efficacy and safety data observed in the APOLLO-B Phase III study and is another step toward bringing patients with the cardiomyopathy of ATTR amyloidosis a novel treatment option that addresses the underlying cause of disease and has the potential to meaningfully benefit patients’ functional capacity and quality of life.” The decision came after the panel’s day-long meeting in which adcomm members discussed whether the treatment effects demonstrated by data from Alnylam’s Phase III APPOLLO-B clinical trial were clinically meaningful for patients with cardiomyopathy induced ...
- Source: drugdu
- 114
- September 15, 2023
FDA Questions Efficacy of Alnylam’s Drug in ATTR-CM Ahead of Adcomm Meeting

By Connor Lynch Pictured: FDA Sign in front of building with blue sky background/Adobe Stock, Grandbrothers Alnylam Pharmaceuticals’ push for patisiran to be expanded to a much larger pool of patients for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis has hit a significant hurdle. In a briefing document released ahead of the Sept. 13 meeting of the FDA’s Cardiovascular and Renal Drugs Advisory Committee, the agency called into question the efficacy of the drug in treating that pool of patients. The company has been seeking approval for its drug patisiran, sold under the brand name Onpattro, to be used to treat patients with cardiomyopathy induced by transthyretin amyloidosis (ATTR-CM). The disease typically affects the hearts and tendons of elderly people, causing an accumulation of proteins which can lead to severe cardiomyopathy. The APOLLO-B study was looking at one key primary efficacy endpoint and one key secondary ...
- Source: drugdu
- 131
- September 14, 2023
Novo Nordisk enters new research alliance for diabetes and cardiometabolic diseases

Novo Nordisk and the Broad Institute of MIT and Harvard have announced a new research alliance to address ‘critical unmet clinical needs’ in diabetes and cardiometabolic diseases. The collaboration aims to identify disease-modifying interventions to improve the standards of care for people living with type 2 diabetes and cardiac fibrosis. The Novo side of the collaboration is secured through the Novo Nordisk Bio Innovation Hub, a research and development unit designed for life sciences innovation and focused on cardiometabolic, rare blood and rare endocrine disorders. Utilising state-of-the-art genetics and genomics methods, the collaboration aims to interrogate subtypes of diabetes. Along with the Broad’s Center for the Development of Therapeutics, using large-scale cell screens, the research will focus on the relationships between genes and pathways that could be therapeutic targets. Type 2 diabetes affects more than 37 million people in the US. Scarring of the heart, or cardiac fibrosis, is common ...
- Source: drugdu
- 108
- September 13, 2023
Bayer bets big on Kerendia’s potential to treat heart failure

Approved two summers ago for chronic kidney disease (CKD) associated with type 2 diabetes, Bayer’s Kerendia (finerenone) isn’t off to the flying start expected of a potential blockbuster. In the second quarter, sales of Kerendia reached 67 million euros ($73 million). For Bayer to achieve its ambitious peak sales target of 3 billion euros ($3.3 billion), it will have to expand the label of the nonsteroidal mineralocorticoid receptor antagonist (MRA). To get there, Bayer is making a big play in heart failure. Thursday, the company said it’s planning three new phase 3 trials in the indication, in addition to one that’s already underway. The new studies will evaluate Bayer’s medicine in roughly 9,000 new heart failure patients with reduced, mildly reduced and preserved ejection fraction. The REDEFINE-HF trial will investigate finerenone as a monotherapy in approximately 5,200 patients with an ejection fraction of greater than 40%. The FINALITY-HF trial will ...
- Source: drugdu
- 107
- September 5, 2023
Low-dose aspirin linked to 15% lower risk of type 2 diabetes in older adults

New research to be presented at this year’s Annual Meeting of the European Association for the Study of Diabetes (EASD) in Hamburg, Germany (2-6 October) shows that use of low dose (100mg daily) aspirin among older adults aged 65 years and older is associated with a 15% lower risk of developing type 2 diabetes. The authors, led by Professor Sophia Zoungas, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia, say the results show that anti-inflammatory agents such as aspirin warrant further study in the prevention of diabetes. The effect of aspirin on incident type 2 diabetes among older adults remains uncertain. This study investigated the randomised treatment effect of low dose aspirin on incident diabetes and fasting plasma glucose (FPG) levels among older adults. The authors did a follow-up study of the ASPREE trial – a double-blind, placebo-controlled trial of aspirin, the principal results of which were ...
- Source: drugdu
- 112
- September 4, 2023
Novo Bolsters Obesity Pipeline with Potential $500M Embark Biotech Buy

By Kate Goodwin Novo Nordisk has again bought a weight-loss focused biotech, as the obesity market heats up. Announced Wednesday, the Danish pharma plans to buy Embark Biotech for $16.3 million up front with close to $500 million on the line in milestone payments—Novo’s second obesity-focused acquisition in three weeks. Novo participated in the seed round for Embark in 2017 when the biotech spun out from Novo Nordisk Foundation Center for Basic Metabolic Research at the University of Copenhagen. The company said it was founded on the discovery of a “novel target that suppresses appetite increases energy expenditure and enhances insulin sensitivity.” The acquisition announced Wednesday gives Novo full rights to develop and commercialize Embark Biotech’s lead metabolic program, currently in preclinical stages. Included is a three-year R&D collaboration with Embark Laboratories, a new company being formed by the biotech’s team to develop therapies for obesity and related conditions, with ...
- Source: drugdu
- 209
- September 1, 2023
BridgeBio Builds ATTR-CM Case for Acoramidis with Promising Phase III Data

By Tristan Manalac Pictured: Ultrasound machine used to obtain images of the heart/iStock, sudok1 Detailed results from the Phase III ATTRibute-CM study showed that BridgeBio Pharma’s acoramidis met its primary endpoint, inducing significant improvements in patients with transthyretin amyloid cardiomyopathy (ATTR-CM), the company announced Sunday. ATTRibute-CM is a randomized and double-blinded study with over 630 patients enrolled. Its primary endpoint is a combination of all-cause mortality, frequency of cardiovascular-related hospitalizations and changes from baseline in NT-proBNP levels and six-minute walk distance (6MWD) performance. Acoramidis achieved a “highly statistically significant result” compared with placebo, BridgeBio wrote in its announcement, touting a Win Ratio of 1.8 with a p-value less than 0.0001. This effect was consistent across NYHA functional classes and between wild-type and variant transthyretin amyloid cardiomyopathy (ATTR-CM) patient subgroups. BridgeBio presented the findings at the 2023 Congress of the European Society of Cardiology, held in Amsterdam over the weekend. The ...
- Source: drugdu
- 107
- August 30, 2023
Wegovy can reduce heart failure symptoms in obese patients, study shows

Data published in The New England Journal of Medicine has demonstrated that Novo Nordisk’s blockbuster weight loss drug Wegovy (2.4mg subcutaneous semaglutide) can reduce heart-failure-related symptoms in people with obesity. The results from a global Phase III trial funded by Novo Nordisk found significant symptom improvement in patients with preserved ejection fraction (HFpEF) – a condition that comprises roughly half of all heart failure cases. In the randomised, placebo-controlled trial (NCT04788511), Wegovy was administered as a 2.4mg weekly dose in 529 patients. After a year, it led to an estimated mean difference of 7.8 points in the Kansas City Cardiomyopathy Questionnaire clinical summary score – a patient-reported outcome for heart failure symptoms and limitations, compared to placebo. Along with leading to a larger reduction in body weight (13.3% versus 2.6%), Wegovy also vastly increased the distance patients were able to walk in six minutes compared to placebo – 21.5 metres ...
- Source: drugdu
- 117
- August 28, 2023
Meta-analysis reports global prevalence of MAFLD of 38.8% in adults

Non-alcoholic fatty liver disease (NAFLD) is a common condition that affects up to 30% of adults in the general population. It is characterized by the accumulation of fat in the liver. It is often associated with other conditions, such as obesity, type 2 diabetes, and metabolic syndrome. The new definition of metabolic dysfunction-associated fatty liver disease (MAFLD) was proposed in 2020. MAFLD is diagnosed based on hepatic steatosis (fatty liver) and at least one of three metabolic risk abnormalities: overweight/obesity, type 2 diabetes, or evidence of metabolic dysregulation. A recent meta-analysis led by Ming-Hua Zheng from the First Affiliated Hospital of Wenzhou Medical University has reported a global prevalence of MAFLD of 38.8% in adults. MAFLD can progress to cirrhosis and promote the development of some critical extrahepatic diseases, such as cardiovascular disease and chronic kidney disease. MAFLD is a severe condition that can lead to cirrhosis and other health ...
- Source: drugdu
- 185
- August 21, 2023

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