A widely anticipated study found that Novo Nordisk’s top-selling diabetes drug Victoza lowered the risk of a heart attack, stroke and death by 13 percent. The results, which were released Monday at the American Diabetes Association annual meeting, mark only the second time that a diabetes drug has demonstrated such a benefit.
The study, which involved 9,340 adults with type 2 diabetes and a high risk of a cardiovascular disease, also showed that participants given Victoza had a 22 percent lower chance of cardiovascular death. This was statistically significant. As an added bonus, those given Victoza lost about 5 pounds more than those who were on a placebo.
Despite the promising results, reactions have been mixed. In fact, Novo Nordisk stock fell in response.
Based on the fact that LEADER was a large prospective placebo controlled with positive end points for primary prevention of adverse CV events, Novo should be in the process of filing a supplemental NDA for a new indication. They will then be the first to secure the claim for primary prevention, and as the marketing folks remind us claims are everything. The fact that efficacy was proven in a non-inferiority trial, where the statistical burden is higher makes the statistical differences more compelling, even if not numerically large.
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