Novo Nordisk files for FDA approval of CagriSema

Danish pharma major Novo Nordisk (NOV: N) has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for once-weekly CagriSema (cagrilintide and semaglutide) injection, to be used with a reduced-calorie diet and increased physical activity, to reduce excess body weight and maintain weight reduction long term in adults with obesity or overweight in the presence of at least one weight-related comorbid condition.

CagriSema is a fixed-dose combination of a long-acting amylin analogue, cagrilintide 2.4mg, and the GLP-1 receptor agonist, semaglutide 2.4mg. If approved, CagriSema would become the first injectable GLP-1 receptor agonist and amylin analogue combination treatment, the company noted.

The news comes hot on the heels of obesity therapy arch rival Eli Lilly (NYSE: LLY) submitting an NDA for its newest candidate in the sector, orforglipron, as the companies battle to gain sales in a market sector forecast to reach $100 billion the end of this decade. The companies are already generating mega-billion dollar sales with their respective semaglutide and tirzepatide brands