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 ...
The European Medicines Agency has identified risks of self-harm and suicidal ideation that could potentially be linked to Novo Nordisk’s medications containing the active ingredients semaglutide and liraglutide. The potential risks were first identified by the Icelandic Medicines Agency, according to a CNN report, citing the EMA. Iceland’s regulator documented one case of suicidal ideation in a patient who had taken the diabetes drug Ozempic (semaglutide) and another after using the weight-loss medicine Saxenda (liraglutide). A third incident involving thoughts of self-harm was also detected in a patient who was receiving Saxenda. The Pharmacovigilance Risk Assessment Committee (PRAC), the EMA’s main group responsible for assessing and monitoring the safety of drug products, has put both treatments under review. The committee is also evaluating whether it will need to extend the review to other products in this drug class, according to CNN. This class, called GLP-1 receptor agonists, include Novo’s Wegovy, Victoza, and Rybelsus, as well as ...
Kyle LaHucik May Associate Editor A few months after the FDA approved the weight loss drug Wegovy for adolescents, researchers are out with a post-hoc look at the late-stage data, this time finding that 45% of the teens taking Novo Nordisk’s drug dipped below the clinical cutoff for obesity. The analysis, presented by University of Minnesota pediatrics professor Aaron Kelly at this week’s European Congress on Obesity in Dublin, gives new insight into the popular drug, which is part of the ballooning obesity R&D field that has Novo and Eli Lilly in the lead and biopharmas like Amgen and Boehringer Ingelheim racing to catch up. The results from the same study, the STEP TEENS trial, were published in the New England Journal of Medicine last December, shortly before the FDA expanded the original 2021 label for adults to include teens 12 years old and older. Almost three-quarters (74%) of teens ...
Novo Nordisk has moved into sickle cell disease through a licensing deal (PDF) with EpiDestiny. The $400 million deal gives Novo worldwide rights to an epigenetic treatment of the disease that is closing in on the start of a phase 2 trial.
Antimicrobial resistance is a global threat to human health. Novo Holdings today announces the launch of an impact fund commissioned by the Novo Nordisk Foundation with a total budget of USD 165 million to invest in companies involved in discovering and early-stage development of therapies to combat antimicrobial resistance.
Novo Nordisk’s diabetes drug Victoza is now approved in Europe as the only GLP-1 analogue with a label including prevention of cardiovascular events.
Denmark-based, Novo Nordisk developed a drug that stimulates insulin productions called semaglutide a class of drugs which categorized in GLP-1s. The new oral diabetes medicine is a better lowering blood sugar levels compared to the existing drug.
Novo Nordisk announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the US Food and Drug Administration (FDA) voted 16-0 in favour of the approval of once-weekly semaglutide to improve glycaemic control in adults with type 2 diabetes. One member of the committee abstained.
On November 6, Novo Nordisk released its third-quarter report for 2024. In the first nine months of this year, sales increased by 23% to 204.7 billion Danish kroner, of which sales of diabetes and obesity treatment drugs increased by 25% to 191.8 billion Danish kroner. The star product Semaglutide continued to advance by leaps and bounds, with sales of three brands (sugar-lowering injection Ozempic, sugar-lowering tablets Rybelsus, and weight-loss injection Wegovy) reaching 141.213 billion Danish kroner, or about 20.3 billion US dollars, in the first nine months of this year. Not long ago, Eli Lilly also announced its performance, among which the sales of two brands of GIPR/GLP-1R dual agonist Tirzepatide (Mounjaro, a hypoglycemic injection, and Zepbound, a weight loss injection) reached US$11.0284 billion in the first three quarters of this year. Specifically, Mounjaro’s sales revenue was US$8.010 billion, and Zepbound’s sales revenue was US$3.018 billion. Zepbound has been rapidly ...
Collective procurement ‘big winner’ In 1995, Gan Zhongru, who had worked as a postdoctoral fellow and senior biochemist at Merck&Co. in the United States, returned to China to start a business. Three years later, the team formed by Gan Zhongru developed China’s first genetically recombinant human insulin, becoming the third company after Eli Lilly and Novo Nordisk to produce and sell recombinant human insulin. Subsequently, under the leadership of Gan Zhongru and his R&D team, Gan Li Pharmaceutical continued to develop the first long-acting insulin analog, the first fast acting insulin analog, the first pre mixed insulin analog, and the first winter insulin in China. The products covered three insulin functional segments: long-acting, fast acting, and medium acting, becoming the “king of insulin” in China. With the acceleration of domestic insulin substitution in recent years, Ganli Pharmaceutical’s operating revenue has increased from 1.771 billion yuan in 2016 to 3.612 billion ...
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