The U.S. FDA has accepted the NDA for an oral formulation of Novo Nordisk A/S’s Wegovy (semaglutide) in treating obesity. If approved, the daily pill will be the first oral GLP-1 for treating chronic weight management. So far, however, it has been injectables leading the way to approval.
Pfizer Inc. is ending work on oral GLP-1 candidate danuglipron for weight loss following the report of a single potentially drug-induced liver injury, a move that appears to open the door for other firms working on oral therapies in the high-dollar obesity space, even as industry watchers seek further details to determine whether similar safety signals could emerge for those competitors.
A late 2024 CMS proposal to include obesity drugs like Novo Nordisk A/S’ Wegovy (semaglutide) and Eli Lilly and Co.’s Zepbound (tirzepatide) under Medicaid and Medicare didn’t make it far under the new U.S. administration. A final rule, set to be published in the Federal Register April 15, will not include the provision that would have added obesity drugs to Part D coverage beginning in 2026.
Rhythm Pharmaceuticals Inc.’s sales with Imcivree (setmelanotide) in weight management could exceed $1 billion by 2028 if hypothalamic obesity (HO) is added to the label of the drug, Oppenheimer analyst Leland Gershell said in a report. Boston-based Rhythm rolled out positive top-line data from the pivotal phase III study called Transcend with the melanocortin-4 receptor agonist in HO. The global trial met its primary endpoint with a statistically significant and highly clinically meaningful reduction in body mass index in adult and pediatric HO patients vs. placebo.
The latest obesity contender, Antag Therapeutics A/S, has dosed the first participants in a phase I trial of a glucose-dependent insulinotrophic polypeptide (GIP) agonist it said will address key gaps in the current treatment options, not least the gastrointestinal side effects seen with GLP-1 agonists.
Building upon its already impressive obesity drug portfolio, Novo Nordisk A/S has licensed a triple agonist of the receptors for GLP-1, GIP and glucagon from United Biotechnology Co. Ltd. China-based United is getting $200 million up front and the chance to earn up to $1.8 billion in milestone payments. United Biotechnology retains the rights to subcutaneously administered UBT-251, which is in the early stages of development for treating obesity, type 2 diabetes and other diseases, in China, Hong Kong, Macau and Taiwan while Bagsværd, Denmark-headquartered Novo get exclusive rights to develop, manufacture and commercialize the triple agonist receptor across the rest of the world.
Building upon its already impressive obesity drug portfolio, Novo Nordisk A/S has licensed a triple agonist of the receptors for GLP-1, GIP and glucagon from United Biotechnology Co. Ltd. China-based United is getting $200 million up front and the chance to earn up to $1.8 billion in milestone payments. United Biotechnology retains the rights to subcutaneously administered UBT-251, which is in the early stages of development for treating obesity, type 2 diabetes and other diseases, in China, Hong Kong, Macau and Taiwan while Bagsværd, Denmark-headquartered Novo get exclusive rights to develop, manufacture and commercialize the triple agonist receptor across the rest of the world.
Histoindex Pte Ltd. launched its laboratory-developed test for metabolic dysfunction-associated steatohepatitis (MASH), Fibrosight, in the U.S. as the company’s first in a suite of next-generation digital pathology solutions.
In what it says is the biggest obesity deal to date, Zealand Pharma A/S has signed up Roche AG to a potential $5.3 billion global collaboration and license agreement to develop petrelintide, an amylin analog that is currently in phase IIb development. The two companies will co-develop and co-commercialize petrelintide and combination products, including a fixed-dose combination of petrelintide and CT-388, Roche’s dual GLP-1/GIP receptor agonist.
Abbvie Inc. is buying into the obesity fray in a potential $1.875 billion development and commercialization agreement with Danish peptide drug discovery specialist Gubra A/S. In addition, there will be a $350 million up-front payment as Abbvie takes over the reins of GUB-014295 (referred to as Gubamy), a long-acting analog of the satiety hormone amylin, currently in phase I development.
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