Encouraged by evidence of the impact that its diabetes drug semaglutide can have on obesity, with patients shedding an average of 16% of their weight in a mid-stage study, top researchers at Novo Nordisk today unveiled an ambitious late-stage strategy to make their mark in a tough, but potentially blockbuster market.
Novo Nordisk has announced that the European Medicine Agency’s advisory committee has recommended Awiqli (once-weekly basal insulin icodec) to treat diabetes in adults. The recommendation from the Committee for Medicinal Products for Human Use (CHMP) was based on positive results from the phase 3a ONWARDS clinical trial programme. Estimated to affect 415 million people worldwide, diabetes is a chronic disease that occurs when the pancreas does not produce enough insulin, a hormone that regulates glucose, or when the body cannot effectively use the insulin it produces. Awiqli works to cover the basal insulin requirements for a week with a single subcutaneous injection. Comprising six phase 3a global clinical trials involving more than 4,000 adults with type 1 or type 2 diabetes, the ONWARDS clinical development programme investigated the efficacy and safety of Awiqli. Results from the programme showed that Awiqli achieved a superior blood sugar reduction and superior time in ...
Dangerously low levels of blood sugar—attributed to counterfeit versions of Novo Nordisk’s Ozempic—hospitalized three people in the United States last year, the American Association of Poison Control Centers (AAPCC) told Reuters. In all last year, the AAPCC revealed that there were 3,316 calls from users of semglutide, the active ingredient in Ozempic. It was more than double the number of calls from the previous year and a 15-fold increase from 2019, according to CNN. Most of the calls were for severe episodes of the commonly known side effects of semaglutide, which include nausea, vomiting and stomach pain. Most cases were resolved with intravenous fluids and nausea medications. Of the three dangerous U.S. cases of low blood sugar, also known as hypoglycemia, the AAPCC suspected the users were supplied with fake versions of semaglutide. All three cases were reported from the same regional poison control center, of which there are 55 ...
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 ...
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 ...
Collaboration based on Valo’s large human dataset and computation powered by artificial intelligence. Image Credit: Adobe Stock Images/Shutter2U Novo Nordisk and Valo Health revealed that they have struck a deal to discover and develop novel treatments for cardiometabolic diseases based on Valo’s large human dataset and computation powered by artificial intelligence (AI). According to Novo Nordisk, this will include access to real-world patient data, AI-enabled small molecule discovery and Biowire human tissue modeling platform designed to speed up the discovery and development process. As per terms of the deal, Valo will receive an upfront payment and a potential near-term milestone payment of $60 million, with the potential to earn additional milestone payments up to $2.7 billion, plus R&D funding and potential royalty payments. “Artificial Intelligence and machine learning hold the promise to positively impact drug discovery and development, in particular enabling our vision of leveraging human datasets early in the ...
As Novo Nordisk and Eli Lilly rack up significant sales from their GLP-1 diabetes and obesity drugs, the companies also must gear up for defense against lawsuits from new users. Case in point is a claim from a Louisiana woman who is suing both companies, alleging her use of Novo’s Ozempic (semaglutide) and Lilly’s Mounjaro caused her to vomit so much that some of her teeth have fallen out. Jaclyn Bjorklund, 44, who used Ozempic for more than a year and then switched to Mounjaro, says the companies failed to warn patients of “severe gastrointestinal events” that can be caused by using the injected drugs. The lawsuit claims that Bjorklund has suffered from “severe vomiting, stomach pain, gastrointestinal burning,” and has been hospitalized for stomach issues on “several” occasions. The prescribing labels for Ozempic and Mounjaro say the drugs “delay gastric emptying” and warn of the risk of gastrointestinal adverse ...
In the rush to supply prescriptions of Novo Nordisk’s popular diabetes and weight loss meds, some pharmacies are making unauthorized versions of Ozempic and Wegovy, the FDA warned on Tuesday. Some compounding pharmacies, which are permitted to make drugs during times of shortage, are using unauthorized versions of semaglutide—the key active ingredient in the GLP-1 drugs. Compounding pharmacies are currently allowed to make Ozempic and Wegovy because they are in short supply. But they must use approved ingredients, the FDA points out. The agency has received adverse event reports after patients have used compounded semaglutide. In some cases, compounders may be using salt forms of semaglutide, called semaglutide sodium or semaglutide acetate, which have not been proven to be safe or effective. The FDA asks users of Ozempic and Wegovy to get a prescription from a licensed provider and only obtain drugs from state-licensed pharmacies or outsourcing facilities registered with ...
An oral drug made by Pfizer causes a similar amount of weight loss as rival Novo Nordisk’s blockbuster injection Ozempic, according to a peer-reviewed study of phase 2 clinical trial results released Monday. The results were presented at a medical conference late last year, and did not compare Pfizer’s drug with Ozempic or other weight loss medications. JAMA Network only now is releasing a peer-reviewed study. Pfizer’s trial followed 411 adults with Type 2 diabetes who either took the company’s pill, danuglipron, twice a day or a placebo. Body weight was “statistically significantly reduced” after patients took either 120-milligram or 80-milligram versions of danuglipron for 16 weeks, the study found. Patients who took a 120-milligram version lost around 10 pounds on average over that time period, the study found. Pfizer’s drug could offer an advantage as an oral treatment option rather than a frequent injection. The study results also suggest ...
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