Boehringer Ingelheim could soon stake a claim in the lucrative obesity treatment market after the pharma company said it has advanced a candidate into three Phase III trials following promising data. Survodutide, the company’s glucagon/glucagon-like peptide 1 (GLP-1) receptor dual agonist co-developed with Zealand Pharma, demonstrated up to 19% weight loss after 46 weeks of treatment in a Phase II dose escalation trial investigating the drug in patients living with obesity without type 2 diabetes (T2D). In a statement announcing the plans, Boehringer Ingelheim said that insights from previous studies will be used to inform the design of the three Phase III trials which will investigate the efficacy and safety of survodutide. Enrolment of patients is planned before the end of 2023, with the company saying that study details will be unveiled nearer to trial commencement. Survodutide has previously received a US Food and Drug Administration (FDA) fast track designation ...
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 ...
Amongst fierce competition in the obesity space, Novo Nordisk has spent $1bn to acquire Inversago Pharma to shore up its weight loss treatment portfolio. The acquisition is expected to be completed by the end of 2023 and will hit the billion-dollar mark, subject to developmental and commercial milestones. The deal, which comes a month after Eli Lilly acquired Versanis and its lead weight loss candidate, bimagrumab, in a $1.9bn deal, will include Inversago’s lead asset INV-202, an oral cannabinoid receptor type-1 (CB1) inverse agonist. Novo Nordisk said it intends to use the candidate for patients with obesity and obesity-related complications. Canada-based Inversago demonstrated the weight loss potential of the candidate in a Phase Ia trial by blocking the CB1 receptor, which plays an important role in appetite regulation and metabolism. INV-202 is currently in a Phase II trial for diabetic kidney disease (NCT05514548). Prior to the 10 August announcement, Novo ...
Amazon has announced that its online healthcare business, Amazon Pharmacy, will provide automated manufacturer-sponsored coupons for over 15 insulin and diabetes medicines to help patients access discounts pledged by the drug industry. The company said that patients will not need to search for and manually enter coupons using the new automatic coupon programme for three insulin makers: Novo Nordisk, Eli Lilly and Sanofi, lowering costs to as little as $35 a month. In March 2023, Novo, Lilly and Sanofi announced that they would be lowering their insulin prices by around 70% by or in 2024. A report published in July by Senator Elizabeth Warren said that some patients were struggling to get already discounted generic insulin from pharmacies at the guaranteed lower price. After Lilly lowered its Insulin Lispro list price in May to $25 per vial, patients were still being quoted up to $330 for the medicine and were ...
As companies have flocked to compete in the new respiratory syncytial virus (RSV) vaccine market, GSK has had the best timing. In May, the U.K. company was first to secure FDA approval for its shot Arexvy for adults 60 and older, beating out rivals from Pfizer and Moderna. And now—well in advance of the fall and winter RSV season—Arexvy is available in major U.S. retail pharmacies, GSK said Thursday. Under the Inflation Reduction Act, Medicare Part D patients will pay no out-of-pocket expenses for the shot, GSK said. Additionally, under the Affordable Care Act, patients with commercial insurance may be covered when Arexvy is administered in-network, GSK said. In June, the Advisory Committee on Immunization Practices (ACIP) recommended that people 60 and older decide in consultation with their healthcare provider whether to receive the RSV vaccine. As people age, their immune systems can become compromised, making them more vulnerable to ...
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 Meg Tirrell, CNN The weight loss drug Wegovy was shown to reduce the risk of heart attack, stroke or heart-related death by 20% in what’s being called a landmark clinical trial in people with cardiovascular disease, the first to show a weight loss drug alone can have such protective effects. Novo Nordisk studied Wegovy against placebo in addition to standard of care for prevention of major adverse cardiac events in 17,604 adults with heart disease and obesity or who were overweight, but who didn’t have diabetes. It called the five-year trial “Select.” The finding of a 20% reduction in heart risk is higher than many experts had anticipated. A similar trial for the type 2 diabetes drug Ozempic, which uses the same ingredient, semaglutide, previously showed it could reduce cardiovascular risk by 26% — but no trial had yet shown a risk reduction in people without diabetes. “Historically, trials ...
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 ...
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