Drug maker Novo Nordisk is weighing its options for releasing data from an important cardiovascular risk study involving its Type 2 diabetes medication Victoza, hoping the drug can show encouraging results in light of the unprecedented success of Eli Lilly and Boehringer Ingelheim’s diabetes drug Jardiance, which showed it cut cardiovascular death in patients by a staggering 32 percent.
The Food and Drug Administration (FDA) has ordered manufacturers of newer type 2 diabetes drugs to conduct long-term post marketing studies on their diabetes medications focusing on cardiovascular effects. The ruling came after the agency severely restricted use of the diabetes drug Avandia after studies linked it to fatal heart attacks.
Lilly and Boehringer announced the results from their drug Jardiance last year, which sent sales of the drug upward.
Novo Nordisk’s data on Victoza is expected by the end of the first quarter of 2016, with full results likely to be presented at the American Diabetes Association annual meeting in June. The drug company said it may run another clinical trial on Victoza, if necessary.
“We are preparing ourselves for different scenarios,” Chief Science Officer Mads Krogsgaard Thomsen told Reuters. “If it is borderline, what I would strongly consider doing is another study. We are already doing the exercise to work out what kind of study we would do and with what kind of patients.”
Victoza is already a strong earner for Novo Nordisk in the diabetes market. The company also managed to stretch sales by rebranding the medication as Saxenda, as a treatment for obesity.
But Novo Nordisk will also have to hope the cardiovascular benefits outshine the risks of the drug. Recent studies have linked Victoza to a painful inflammation of the pancreas known as acute pancreatitis. The drug has also been linked to pancreatic cancer and thyroid cancer.