Novo Nordisk to Resubmit Wegovy Heart Failure Application with Updated Clinical Data

Denmark’s pharmaceutical giant, Novo Nordisk (NYSE: NVO), has reported significant findings on the efficacy of its weight management drug semaglutide, marketed as Ozempic for diabetes and Wegovy for obesity, in managing heart failure conditions. The data, published in The Lancet, encompasses results from 3,743 participants across four pivotal clinical trials: SELECT, FLOW, STEP-HFpEF, and STEP-HFpEF DM.

In the trials, semaglutide was administered at a 2.4mg weekly dose, yielding promising results. The drug demonstrated a 31% reduction in the risk of cardiovascular death or heart failure exacerbation, with an incidence rate of 5.4% in the semaglutide group compared to 7.5% in the placebo group. Furthermore, the risk of heart failure worsening was reduced by 41% in the treatment group (2.8% vs. 4.7% with placebo). However, there was no notable impact on the rate of cardiovascular death (3.1% with semaglutide vs. 3.7% with placebo).

Treatment-related adverse events that led to discontinuation were higher in the semaglutide group, affecting 21% of patients, compared to 13.9% in the placebo group.

Semaglutide, a GLP-1 receptor agonist, is currently approved in the U.S. for obesity treatment as Wegovy and for reducing cardiovascular risk in patients with overweight or obesity and established cardiovascular disease. It is also used for type 2 diabetes treatment under the brand name Ozempic. In its financial report for Q2 2024, Novo Nordisk announced the withdrawal of its filing for Wegovy as a heart failure treatment, with plans to resubmit in 2025, incorporating data from the FLOW trial to strengthen the submission. – Flcube.com

Fineline Info & Tech