Novo Nordisk’s blockbuster weight loss injection Wegovy could prevent up to 1.5 million heart attacks, strokes and other cardiovascular events in the U.S. over 10 years, according to a study released this week. Researchers from the University of California, Irvine, also found that Wegovy could result in 43 million fewer Americans with obesity over a decade. Notably, the study was partly funded by Novo Nordisk. The study results complement the initial data the Danish company released last week from a large clinical trial, which found that Wegovy slashed the risk of serious heart problems and heart-related death by 20%. Novo Nordisk’s trial studied overweight or obese patients with established cardiovascular disease, while UC Irvine’s study examined similar patients, albeit without the disease. Together, the results suggest that Wegovy and, likely, similar obesity drugs have significant health benefits beyond shedding unwanted pounds. Physicians and Wall Street analysts hope that could eventually ...
By Tristan Manalac Novo Nordisk’s weight-loss medication Wegovy (semaglutide) met its primary efficacy endpoint in the Phase III SELECT trial, demonstrating strong protective effect on cardiovascular health in overweight and obese adults without diabetes, the company announced Tuesday. At a 2.4-mg dose level, once-weekly Wegovy injections significantly reduced the occurrence of major adverse cardiovascular events (MACE) by 20% as compared with placebo. This treatment effect was statistically significant, according to Novo’s announcement. Wegovy’s safety profile in SELECT was also in line with what had been established in previous studies. SELECT defined MACE as a composite of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke. Wegovy reduced the frequency of all three MACE components in SELECT. Novo was trading approximately 11% higher in pre-market Tuesday following the data drop. The results from SELECT highlight the potential dual benefits of Wegovy for overweight and obese adults who suffer from a heightened risk ...
Novo Nordisk has been riding the momentum of weight loss drug Wegovy ever since it stormed onto the market in 2021, creating widespread hype and even some supply shortfalls. But, now, a cardio outcomes trial could seriously change the game for the burgeoning medicine. In a large phase 3 trial, the drug cut the risk of major adverse cardiovascular events by 20% compared with placebo and standard of care, Novo said Tuesday. Specifically, investigators measured Wegovy’s 2.4-mg dose for its ability to cut the risk of a cardio death, heart attack or stroke. The trial enrolled 17,604 people and tested the drug for up to five years in people 45 and older who were overweight or obese and who had established cardiovascular disease. To be eligible for the trial, patients had to have had no history of diabetes. Based on the trial win, Novo Nordisk said it expects to seek ...
Dive Brief Analysts at Needham expect a U.S. Food and Drug Administration advisory panel to support the safety and efficacy of Medtronic’s renal denervation device at a meeting later this month. The meeting, which the FDA scheduled in June, will enable experts in circulatory system devices to discuss the evidence on Medtronic’s Symplicity Spyral and ReCor Medical’s rival renal denervation system. While the analysts expect Medtronic to face questions over the failure of its pivotal trial, they think the experts will vote in favor of the device, putting it on track to target a $1 billion-plus market. Dive Insight Medtronic’s multi-year effort to build confidence in renal denervation as a way to treat high blood pressure hit a snag late last year when a pivotal trial found it worked no better than drugs alone at reducing patients’ blood pressure at home. However, while the missed endpoint was an unwelcome development ...
Eli Lilly has announced positive top-line results from a late-stage study of its targeted therapy Retevmo (selpercatinib) versus the current first-line standard of care in certain non-small cell lung cancer (NSCLC) patients. The phase 3 LIBRETTO-431 trial has been evaluating Retevmo versus platinum-based chemotherapy plus pemetrexed with or without Merck’s Keytruda (pembrolizumab) as an initial treatment for adults with rearranged during transfection (RET) fusion-positive advanced or metastatic NSCLC. A pre-specified interim efficacy analysis showed that the study met its primary endpoint, with Lilly’s therapy demonstrating a statistically significant and clinically meaningful improvement in progression-free survival. As the company outlined, LIBRETTO-431 is the first randomised study to compare the safety and effectiveness of a targeted therapy to a PD-1 inhibitor plus chemotherapy in cancer patients bearing a specific biomarker. David Hyman, chief medical officer at Loxo@Lilly, said: “The LIBRETTO-431 trial aims to answer an important question about the selection of initial ...
Published in the International Journal of Obesity, University of Minnesota Medical School and School of Public Health researchers led a study on the relationship between dietary intake and cardiovascular disease risk factors. Over 20 years, the research team examined people’s regular dietary intake, paying particular attention to non-nutritive sweeteners commonly found in artificial sweeteners. They found that long-term consumption of aspartame, saccharin, and diet beverages were linked to increased fat stores in the abdomen and fat within muscle. However, the study found no significant association between the artificial sweetener sucralose and these measures of fat volume. Brian Steffen (PhD, MSCR, Professor, Department of Surgery, University of Minnesota Medical School) said, “This study showed that habitual, long-term intake of total and individual artificial sweetener intakes are related to greater volumes of adipose tissue, commonly known as body fat. This was found even after accounting for other factors, including how much a ...
Roche has entered into a new partnership with Alnylam Pharmaceuticals to develop and commercialise a potential treatment for high blood pressure, with the deal worth up to $2.8bn. The candidate, zilebesiran, is an investigational, subcutaneously administered RNAi therapeutic currently in phase 2 development to treat hypertension in populations with high-unmet needs. Under the terms of the agreement, which provides Roche with exclusive commercialisation rights to the therapy outside of the US and joint commercialisation rights within the country, Alnylam will receive an upfront payment of $310m and is also eligible to receive certain milestone payments. Hypertension, the leading cause of cardiovascular disease, affects more than 1.2 billion adults worldwide. While several therapies exist, a significant unmet need remains, especially for high-risk patients. Zilebesiran works by preventing the production of angiotensinogen, a protein that plays a key role in raising blood pressure, in the liver. ...
Photo: Giuseppe Aresu/Bloomberg, via Getty Images Alnylam pioneered RNA interference drugs for rare disease. The biotech aims to bring RNAI to prevalent disorders and its alliance with Roche on the drug zilebesiran for hypertension better positions the company to achieve this goal. Cardiometabolic disease isn’t a big part of Roche’s drug portfolio or pipeline, but the pharmaceutical giant is trying to change that with a deal to share in the development of an experimental Alnylam Pharmaceuticals hypertension drug that could offer patients efficacy and dosing advantages. According to deal terms announced Monday, Roche is paying $310 million for outside-of-the-U.S. rights to the drug, zilebesiran. The companies will share in the development of the RNA therapy for hypertension. Roche has the opportunity to lead future development of the drug for other indications. Cambridge, Massachusetts-based Alnylam is a pioneer among companies developing therapies that leverage RNA interference, a pathway in ...
Sanofi is interested in Recludix Pharma’s approach to treating inflammation with an oral small molecule that targets a protein thought to be undruggable. If it works, the drug could have safety and dosing advantages over currently available biologic drugs, including blockbuster Sanofi drug Dupixent. By FRANK VINLUAN Photo: Nathan Laine/Bloomberg, via Getty Images Sanofi is a dominating presence in inflammation and immunology with Dupixent, a blockbuster drug whose sales continue to grow in multiple approved indications. That product is an antibody administered by injection, so several companies are vying to compete by developing oral alternatives. Now Sanofi is joining them. The Paris-based pharmaceutical giant has struck up a partnership with Recludix Pharma. The deal focuses on the biotech’s preclinical oral small molecules, which have potential applications in a range of immunological and inflammatory diseases. Sanofi has committed to $125 million in near-term payments to Recludix to begin the alliance. San ...
The European Commission, the Heads of Medicines Agencies (HMA), and the European Medicines Agency (EMA) have issued recommendations to prevent shortages of antibiotics. Drug shortages have become the norm in recent years, with the US Food and Drug Administration (FDA) reporting 295 active shortages in the last quarter of 2022 and the EMA reporting that a shortage of cardiovascular medications is expected to continue until next year. The EMA has said that the EU has an adequate supply of oral antibiotics for the treatment of respiratory infections, if the demand remains comparable to previous years, as per a 17 July press release. Nonetheless, the agency has issued several recommendations to ensure robust preparedness. It has also announced plans to engage with marketing authorisation holders to increase production and continue to monitor supply and demand without resorting to stockpiling. In addition, the agency wants to increase ...
Go to Page Go
your submission has already been received.
OK
Please enter a valid Email address!
Submit
The most relevant industry news & insight will be sent to you every two weeks.