Search Results for “cardiovascular” – Page 26 – media

Novo Nordisk says Wegovy can help heart disease patients—and not just because it produces weight loss

Novo Nordisk has made a splash with its GLP-1 drugs that have allowed patients to achieve significant weight loss. Now the Danish company appears on the verge of another breakthrough, showing that the use of its obesity treatment Wegovy can reduce the risk of heart attack in some patients. Perhaps even more importantly, Novo said this weekend in Philadelphia at the American Heart Association (AHA) Scientific Sessions that the cardiovascular benefits gained from Wegovy aren’t due solely to weight loss. The phase 3 SELECT trial showed that use of Wegovy versus placebo lowered the risk of a non-fatal heart attack by 28% and the risk of progression of chronic kidney disease and renal death by 22%. Additionally in the study—which included nondiabetic obese and overweight patients with established cardiovascular disease—Wegovy was found to reduce the risk of heart-related death by 15% and the risk of death by any cause by ...
- Source: drugdu
- 97
- November 15, 2023
FDA Approves Takeda’s Treatment for Rare Blood Clotting Disorder

Adzynma is the first approved genetically engineered protein product for the treatment of patients with congenital thrombotic thrombocytopenic purpura. The FDA has approved Takeda’s Adzynma as the first genetically engineered protein medication for the preventative treatment or for on-demand enzyme replacement therapy in patients with congenital thrombotic thrombocytopenic purpura (cTTP). Image credit: olegganko | stock.adobe.com The FDA granted the application for Adzynma with a Rare Pediatric Disease Priority Review Voucher, as well as Priority Review, Fast Track, and Orphan designations. cTTP affects fewer than 1,000 individuals in the United States. “The FDA remains deeply committed in our efforts to help facilitate the development and approval of safe and effective therapies for patients with rare diseases,” said FDA Director of the Center for Biologics Evaluation and Research Peter Marks, MD, PhD, in a press release.1 “Without treatment, cTTP is ultimately fatal. Today’s approval reflects important progress in the development of ...
- Source: drugdu
- 100
- November 13, 2023
With FDA approval, Eli Lilly’s weight-loss drug Zepbound arrives to challenge Novo Nordisk

In the Big Pharma battle to treat obesity, Novo Nordisk sprinted to an early lead, but Eli Lilly is catching up quickly. Wednesday, the Indianapolis-based company scored FDA approval for its GIP/GLP-1 compound tirzepatide to treat obesity, which will allow broader access to the treatment in the U.S. Dubbed Zepbound, Lilly’s new product is the same formula as blockbuster Type 2 diabetes drug Mounjaro. Since it was endorsed by the FDA in May 2022, Mounjaro has gained widespread, off-label use to treat obesity. Now, Zepbound has been indicated for adults with a BMI of 30 or higher as well as those with a BMI of 27 or higher with weight-related problems such as hypertension, Type 2 diabetes, sleep apnea or cardiovascular disease. With the FDA nod, Lilly now has its answer to Novo’s blockbuster duo of Ozempic for diabetes and Wegovy for obesity. The Danish company gained FDA green lights ...
- Source: drugdu
- 102
- November 10, 2023
FDA Approves Eli Lilly Weight Drug, Now Set to Compete Against Novo’s Wegovy

Eli Lilly weight management drug Zepbound landed its much anticipated FDA approval. The new Lilly product is in the same drug class as Novo Nordisk weight medication Wegovy, but it offers an additional mechanism of action and costs less. By FRANK VINLUAN A blockbuster Eli Lilly drug for type 2 diabetes now has an additional FDA approval in chronic weight management, a regulatory decision that positions the pharmaceutical giant to more directly compete in cardiometabolic conditions against a Novo Nordisk molecule that has become a sales juggernaut in its own right. Lilly’s new drug is the same as its type 2 medication Mounjaro, but it will be marketed under the brand name Zepbound. The Indianapolis-based drugmaker expects Zepbound will become available in the U.S. by the end of this year. The FDA approved Zepbound as a way to help patients lose weight and keep it off. The Wednesday regulatory decision ...
- Source: drugdu
- 104
- November 10, 2023
J&J links radiofrequency catheter to improved quality of life in atrial fibrillation study

Dive Brief Johnson & Johnson has linked its Qdot Micro radiofrequency (RF) catheter to improved quality of life in patients with paroxysmal atrial fibrillation (AFib). The single-arm study found that, compared to baseline, scores on an AFib quality-of-life scale improved and use of antiarrhythmic drugs fell after people underwent treatment with the device. Qdot Micro, which received approval in the U.S. in 2022, is set to face competition from pulsed field ablation (PFA) devices. A Boston Scientific study suggests PFA and thermal ablation result in similar levels of improvement in quality of life. Dive Insight Qdot Micro is temperature-controlled, contact force-sensing, RF catheter. The temperature control feature supports the use of higher radiofrequency power in short bursts, an approach that J&J sees as a way to improve efficacy without compromising safety. J&J published 12-month data on the effectiveness of the device in its Q-FFICIENCY study earlier this year. The latest ...
- Source: drugdu
- 101
- November 9, 2023
Eli Lilly doubles down on obesity pipeline’s potential

Amidst the rapidly growing revenue share of metabolic disease drugs in its pipeline, Eli Lilly is looking to delve deeper into its pharmaceutical exploration of obesity therapeutics, said medical director Axel Haupt. Haupt was speaking at a panel at the ongoing Bio-Europe 2023 conference, where he said drugs like Lilly’s Mounjaro (tirzepatide) carry potential to be used in for several conditions. The US Food and Drug Administration approved Eli Lilly’s Mounjaro for diabetes in May 2022, followed by the European Union in September 2022. The drug is administered via injection in a once-weekly regimen. Haupt revealed that an FDA approval for Mounjaro for treating obesity could be expected within the next 12 months. Obesity and diabetes treatment would likely not be the only use for Mounjaro, given the presence of GIP receptors in other locations like the adipose tissue, Haupt said. Eli Lilly sees potential use for the drug in ...
- Source: drugdu
- 110
- November 8, 2023
Eli Lilly Strikes $250M Deal to Add Gene-Editing Medicines for Cardio Conditions

Eli Lilly is acquiring Beam Therapeutics’ opt-in rights to three Verve Therapeutics gene-editing therapies for cardiovascular conditions. The deal comes four months after the pharmaceutical giant began a partnership on a preclinical Verve gene-editing therapy for a different target. By FRANK VINLUAN Eli Lilly signaled its growing interest in genetic medicines for cardiovascular conditions when it partnered with Verve Therapeutics earlier this year, committing to share in development of a preclinical gene-editing therapy addressing a key heart target. The pharmaceutical giant is now adding more cardiovascular disease drug prospects, pledging $250 million to secure the right to opt into development and commercialization of three additional Verve gene-editing therapies for other key targets. This time, however, the cash isn’t going to Verve. Lilly is paying Beam Therapeutics, whose base-editing technology is used in Verve’s experimental genetic medicines. Their original alliance, started in 2019, gave Beam the option to share in the ...
- Source: drugdu
- 185
- November 2, 2023
Royalty Boosts Struggling PTC with Additional $1B for Royalties on Roche’s Evrysdi

Pictured: Handshake over a deal/iStock, PeopleImages Biopharma’s biggest royalties buyer is upping its stake in a popular spinal muscular atrophy drug. Royalty Pharma announced Thursday a $1 billion upfront payment to beleaguered PTC Therapeutics for additional royalties in Evrysdi, licensed and marketed by Roche. Royalty initially bought into Evrysdi in July 2020, just before its approval by the FDA. The drug has already been used to treat over 11,000 patients worldwide. Spinal muscular atrophy (SMA) is a rare and often fatal genetic disease that typically presents in infants and young children. The deal increases Royalty’s ownership of the Evrysdi royalty from 43% to 81%, equating to 13% of the royalties Roche pays on worldwide net product sales. Roche reported $801.4 million in sales for the first half of 2023. GlobalData predicts sales to rise to just under $3 billion in 2029. In Thursday’s announced deal, PTC has the option to sell the remainder of the Evrysdi royalty to Royalty for up ...
- Source: Kate Goodwin
- 121
- October 21, 2023
Ardelyx Nabs FDA Approval for First Phosphate Absorption Blocker in CKD

Pictured: Test-tube containing a blood sample for measuring serum phosphorus levels/iStock, Md Saiful Islam Khan The FDA on Tuesday gave the greenlight to Ardelyx’s tenapanor, now to be marketed under the brand name Xphozah, indicated to reduce serum phosphorus levels in patients with chronic kidney disease. Tuesday’s approval covers chronic kidney disease (CKD) patients on dialysis who had previously shown an inadequate response to phosphate binders, or who are otherwise intolerant to such therapies. Xphozah’s label bears no boxed warning but carries a precaution against severe diarrhea, the most common observed adverse event during the drug’s development. Ardelyx CEO Mike Raab called Tuesday’s approval an “important milestone” for dialysis patients, their families and the larger nephrology care community. Xphozah “represents a new mechanism and new option for patients who, despite treatment with phosphate binders, continue to have elevated phosphorus.” Xphozah is taken as 30-mg oral tablets twice-daily, before the morning and evening meals. Its ...
- Source: drugdu
- 109
- October 20, 2023
Novo Nordisk to buy KBP’s hypertension drug ocedurenone for up to $1.3bn

Novo Nordisk has agreed to acquire ocedurenone, a drug for uncontrolled hypertension, from KBP Biosciences in a deal worth up to $1.3bn. Ocedurenone, an orally administered, small molecule, non-steroidal mineralocorticoid receptor antagonist, is currently being evaluated in the late-stage CLARION-CKD trial as a treatment option for patients with uncontrolled hypertension as well as for those with advanced chronic kidney disease (CKD). Uncontrolled hypertension is when a person’s blood pressure remains high despite taking two or more blood pressure-lowering treatments. An estimated 1.28 billion adults aged 30 to 79 years worldwide have hypertension and only about 21% have it under control, marking a significant unmet need in the treatment of the condition. Martin Holst Lange, executive vice president and head of development at Novo, said: “Hypertension is a leading risk factor for cardiovascular events, heart failure, CKD and premature death. “With its expected benefit-risk profile, ocedurenone has best-in-class potential in treating ...
- Source: drugdu
- 162
- October 19, 2023

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