Britain’s drug regulator approves Novo Nordisk’s weight loss drug Wegovy to cut heart disease risk in patients with obesity
On Tuesday, the 23rd of July, 2024, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) granted approval for an additional use of Novo Nordisk drug, semaglutide (marketed as Wegovy), targeting the reduction of cardiovascular risks in adults with overweight and obesity.
Originally sanctioned for obesity treatment and weight management in conjunction with dietary, physical, and behavioural interventions, semaglutide, a GLP-1 receptor agonist, has now emerged as the pioneering prescription weight loss medication to thwart cardiovascular incidents. This includes the prevention of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke in individuals possessing a Body Mass Index (BMI) of at least 27 kg/m2 who already suffer from established cardiovascular disorders.
The endorsement by MHRA is supported by recent data derived from a post-approval clinical trial, indicating that a weekly subcutaneous injection of semaglutide (2.4 mg) over a span of up to five years considerably diminishes the occurrence of major adverse cardiovascular events (MACE) when compared to a placebo.
In a significant international study, which randomly allocated more than 17,600 participants to either receive Wegovy or a placebo, the treatment with Wegovy was observed to reduce the risk of major adverse cardiovascular events by 20%. These events transpired in only 6.5% of the Wegovy group, as opposed to 8% among those who received the placebo.
Recent research underscores the efficacy of semaglutide in augmenting the life quality of individuals with cardiovascular diseases by substantially lowering the risk of severe cardiac episodes.
Furthermore, in a strategic expansion move, Novo Nordisk procured a 200-acre plot earlier this month in Odense, Denmark’s third-largest city. The company has initiated preliminary excavation activities at this site, potentially setting the stage for a new manufacturing facility.
The surge in demand has propelled the pharmaceutical giant to invest billions in amplifying its production capacities in both Denmark and the United States. While the specific purpose of the new site in Odense remains to be officially confirmed, a report by Reuters in January highlighted that the site might accommodate facilities crucial for the fill-finish process involved in injection pen manufacturing.
A company statement released to Reuters mentioned, “With the political processes and approvals in place, we are pleased to announce that Novo Nordisk is now the owner of the site in Tietgenbyen in Odense.”
The company further indicated that the decision-making process regarding the precise use of the new site would conclude by the end of the year, post-internal approvals. The environmental report sheds light on future plans, which include establishing a packaging facility by 2026 and a factory for moulding plastic components necessary for pen and possibly tablet production by 2030.
