Novo Nordisk is making a bold move to reshape the obesity treatment landscape with a new high-dose formulation of its drug Wegovy (semaglutide). The pharmaceutical giant aims to offer a tailored solution for patients who haven’t seen results with current dosages or those seeking more dramatic weight loss outcomes.
Industry sources reported on Friday that Novo Nordisk submitted an application to the European Medicines Agency (EMA) on Tuesday for approval of a 7.2 mg Wegovy formulation. This ultra-high dose significantly exceeds the current maximum dosage of 2.4 mg. It is expected to be particularly beneficial for patients with severe obesity or those aiming for substantial weight reduction.
The company framed this application as part of its strategy to expand its portfolio, addressing the diverse weight loss needs of patients with obesity and supporting individual health goals. The existing Wegovy formulation has already proven its efficacy, demonstrating an average weight loss of 15% to 17% with a weekly dose of 2.4 mg.
The STEP UP clinical trial, which formed the basis for the EMA application, yielded promising results. Adults with obesity who received the 7.2 mg semaglutide dose experienced an average weight loss of 21%. Notably, approximately one-third of the participants shed more than 25% of their body weight, indicating the treatment’s potential for patients with moderate to severe obesity.
These weight loss figures are comparable to the highest dosage (15 mg) of Eli Lilly’s rival drug, Zepbound (tirzepatide). The SURMOUNT clinical trials for Zepbound reported average weight reductions of 22% to 24%, with up to 40% of participants losing over 25% of their body weight.
Novo Nordisk is also gearing up to launch its expanded Wegovy portfolio, including the high-dose formulation, across the European Union (EU). Given the supply constraints experienced in the U.S. market, the company is expected to take a measured approach to expansion, carefully balancing production capacity and efficiency to ensure a seamless rollout.
The GLP-1 class of drugs, to which Wegovy belongs, is experiencing explosive market growth. Market research firm Evaluate projects that GLP-1 drugs will grow at an average annual rate exceeding 20% by 2030, capturing approximately 9% of the global prescription drug market. This translates to a staggering market value of roughly $ 160 billion.
Zepbound is forecast to generate annual sales of 62 billion USD. This is double the revenue of Merck’s top-selling cancer drug, Keytruda. Industry analysts suggest that the introduction of Wegovy’s ultra-high-dose formulation could significantly alter the competitive landscape currently dominated by Zepbound.