Novo Nordisk Aims for Weight Loss Drug Milestone as FDA Decision Looms
Pharma giant Novo Nordisk is on the cusp of a significant milestone, aiming to be the first to commercialize an oral version of a GLP-1 weight loss medication. The FDA's decision is expected in late 2023, which could boost the company's fortunes after a year of stock decline due to reduced profit assumptions for its existing weight loss drug, Wegovy.
Novo Nordisk has experience in this area, having successfully navigated the approval process for its oral GLP-1 receptor agonist, semaglutid, in the US for type 2 diabetes treatment. The company's oral Wegovy, specifically designed for weight loss, shows promise in phase 3 trials, outperforming Eli Lilly's orforglipron in terms of adverse effect discontinuation rates and body weight change. If approved first and maintaining this superiority, oral Wegovy could become a significant player in the weight loss market by 2026.
However, Novo Nordisk faces challenges. High-profile quality control issues, supply chain bottlenecks, and increasing competition from Eli Lilly's Zepbound have impacted its profits. Eli Lilly, meanwhile, plans to submit its oral weight loss medication, orforglipron, for regulatory review in obesity in late 2025 and for type 2 diabetes in late 2026.
Novo Nordisk's oral Wegovy could revolutionize weight loss treatment if approved by the FDA later this year. Its success depends on maintaining trial results, navigating regulatory processes, and overcoming competition and operational challenges. Stay tuned for updates from Novo Nordisk and the FDA for the latest developments.
