Despite persistent supply hitches since Wegovy’s launch in 2021, Novo Nordisk has quickly garnered blockbuster sales in the newly untapped obesity market. And to hear Novo’s CEO Lars Fruergaard Jørgensen tell it, the company is “just getting going” in the field. In 2024, Novo Nordisk plans to entrench itself even deeper into the burgeoning obesity market, Jørgensen said Tuesday at the 42nd annual J.P. Morgan Healthcare Conference. To get there, Novo will rely on expanded manufacturing capacity, new cardiovascular outcomes data and a surprise boost from Eli Lilly’s rival weight-loss drug Zepbound, which snagged its own obesity nod in November. Novo’s Wegovy proved immensely popular out the gate. Initially, the company struggled to contend with the unprecedented spike in demand for its new semaglutide-based medicine. But after a sustained manufacturing expansion campaign over the past two years, Jørgensen figures Novo is in a comfortable position moving into 2024. In 2023, ...
Use of Novo Nordisk and Eli Lilly’s popular diabetes and weight loss drugs come with warnings about a rare intestinal blockage condition called ileus, which can be life threatening. Could cautions about more common side effects soon be added to the labels of popular treatments such as Novo’s Ozempic and Lilly’s Mounjaro? On Tuesday, the FDA revealed that it is investigating patient reports of suicidal thoughts and hair loss from the use of the blood sugar-modulating products. The U.S. regulator also is looking into cases of aspiration, a condition often associated with surgery in which people breathe food, liquids, vomit or saliva into their lungs. The investigation was triggered by information gathered on the FDA Adverse Event Reporting System (FAERS), a database that allows the regulator to track potential problems by collecting side effect reports from patients and healthcare providers. Each quarter, the FDA posts a list of drugs that ...
As high-flying Novo Nordisk continues its global manufacturing expansion, the GLP-1 maker has expanded its reach with a $92.5 million plant buy from Alkermes. The deal, which is expected to close in mid-2024, gives Novo the keys to Alkermes’ development and manufacturing site and its approximately 400 employees in Athlone, Ireland, the companies said in a press release. “The acquisition of the Athlone facility represents an expansion of Novo Nordisk’s global manufacturing setup and will provide Novo Nordisk with additional development and manufacturing capacity for current and future oral products,” Novo’s senior vice president of product supply emerging technologies, Thilde G. Hummel Bøgebjerg, said in a statement. The 400 employees Novo will bring on board have “valuable capabilities within oral drug development and manufacturing,” Bøgebjerg added. The staff switchover marks an “exciting opportunity for growth” for the employees, Alkermes CEO Richard Pops added. For now, the companies will ink subcontracting ...
Novo Nordisk has said it will be investing more than $2.3bn to expand its existing production site in France “for the current and future product portfolio within serious chronic diseases”. The investment will “significantly increase” the capacity of the Chartres manufacturing facility, Novo said, including for its GLP-1 products in the cardiometabolic disease space. The site in Chartres was first established in 1961 and currently employs around 1,600 people, with more than 500 new jobs expected to be created as a result of the expansion. Lone Charlotte Larsen, corporate vice president of Novo Nordisk Production Chartres, said: “This significant investment… confirms the importance of our French manufacturing site, one of our strategic production sites, as a cornerstone of the growth we are experiencing as a company. “By maximising the skills and infrastructure we already have on the site, we are expanding our capacity in an efficient way.” The expansion is ...
Novo Nordisk announced plans to expand one of its production facilities in Chartres, France, as it scales up its serious chronic disease product portfolio. Under the Dkr16bn ($2.29bn) investment, Novo Nordisk is increasing the capacity of the manufacturing site by extending the current quality control laboratory, adding aseptic production, and finishing production processes. The company predicts that this will bring over 500 new jobs once construction is completed. According to the press release, the investment includes additional capacity for GLP-1 products such as Novo’s Ozempic (semaglutide). Novo Nordisk first launched the GLP-1 therapy Semaglutide, in the US in December 2017, under the brand name Ozempic. The drug has since been approved in the US, Canada, EU, Japan, and Australia as a treatment for T2D. Novo Nordisk later launched the therapy under the name Wegovy for the treatment of weight loss, together with diet and physical activity. Novo Nordisk is a ...
Unable to scale up its manufacturing fast enough to meet the spiraling demand for its GLP-1 weight loss products, Novo Nordisk is employing a new strategy—reducing production of diabetes drug Victoza to make more Ozempic. Novo and the European Medicines Agency (EMA) divulged (PDF) the move in a letter to healthcare professionals, warning of a growing shortage of both medicines that is set to intensify during the rest of the fourth quarter. With the shortage of Victoza expected to continue into the second quarter of next year, the EMA has instructed healthcare providers not to start new patients on the drug until then. While Victoza (liraglutide) and Ozempic (semaglutide) are both GLP-1 drugs, the former—which was originally approved in 2010—is not used for weight loss. Intermittent shortages of Ozempic are expected to persist throughout 2024, though the overall supply situation should improve in the first quarter of next year, according ...
In response to an onslaught from Eli Lilly, Novo Nordisk is escalating the obesity market battle with a new head-to-head trial against its archrival.Novo has unveiled a new phase 3 trial pitting CagriSema, a fixed-dose combination of Wegovy and the investigational drug cagrilintide, against Lilly’s Zepbound in people with obesity, according to a clinicaltrials.gov entry. The study plans to enroll 800 patients, and those with diabetes are excluded. Its primary goal is to evaluate how well the two companies’ therapies could help people lose weight relative to each other after 72 weeks of treatment.In addition, the trial will measure the number of patients in each arm who’ve achieved at least 25% or 30% weight reduction at the end of treatment. Other secondary endpoints include changes in cholesterol levels, triglycerides, waist circumference, systolic blood pressure and serious side effects. The Novo trial comes about seven months after Lilly launched a head-to-head phase 3 study testing Zepbound—also known ...
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 ...
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 ...
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 ...
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