Novo Nordisk has now registered a new drug application to receive the FDA’s approval stamp. This decision by Novo stems from its competition with Lilly in the weight loss market so far. In a way, this move is an answer to Lilly and the company’s ongoing efforts to regain dominance in the weight loss sector with its effective drug. The drug is a once-weekly injectable obesity drug, CagriSema.
This is the beginning of the new race with Eli Lilly, a challenge that is either way beneficial for the healthcare sector as a whole. As noted, Eli Lilly’s assets are enjoying clinical wins in the $27 billion obesity market. From a business perspective, Novo Nordisk must have something unexpectedly unique and convincing drug application to win against this giant.
The application inks the use of the medicine in the adult population who are overweight or suffering from obesity, along with one weight-based comorbidity. Under the application, the company describes CagriSema as a merger of a long-reactive amylin analogue, cagrilintide. Following this drug, to just mention the Novo’s GLP-1 receptor agonist semaglutide has also received approval as Ozempic for diabetes and Wegovy for obesity.
The company has hyped CagriSema during the announcement. Novo praised that its new drug is a potential and the first of its kind injectable amylin-GLP-1 merger therapy in the sector. This confident filing is related to the results from the company’s Phase 3 REDEFINE 1 trial. Last year, a reference from REDEFINE 1 highlighted CagriSema to meet 20.4% weight loss after 68 weeks v/s 14.9% with semaglutide alone, 3% for the placebo group and 11.5% with cagrilintide alone.
Based on the readout from the REDEFINE 1 trial in depth, the company confirmed CagriSema as a promising drug in comparison to Lilly’s GLP-1 Zepbound. Novo is in a fair battle to make its drug application win. The CEO of Novo Nordisk, Maziar Mike Doustdar, said, “Standing tall on the well-developed profile of semaglutide and merging it with a novel mechanism of action, the CagriSema can mark a significant step in the full-fledged treatment of obesity.”
Apart from Novo, Danish pharma is also standing in the queue to hear the FDA’s verdict on its oral semaglutide pill. Alongside, Lilly also proudly announced its major milestone for the success of its oral offering orfoglipron, by maintaining weight loss in patients who replaced Lilly’s GLP-1 Zepbound or Wegovy.