Victoza disappoints on cardio benefits, lifts rival Jardiance
Competition is intensifying around which pharma company has the diabetes drug with the best data on preventing heart attacks and strokes.
The FDA and other regulators require cardiovascular safety studies for diabetes medicines – but pharma companies have turned this to their advantage and are now looking for drugs with a dual action, not only lowering blood sugar levels, but also bringing a cardiovascular benefit.
Novo Nordisk's Victoza (liraglutide) has become the only approved diabetes drug in the GLP-1 agonist class shown to demonstrate a cardiac safety benefit, although it faces competition from a Lilly/Boehringer drug in the SGLT2 inhibitor class.
Data from the LEADER trial involving 9,340 adults with type 2 diabetes, showed Victoza reduced risk of a composite primary cardiac event endpoint by 13% compared with placebo when added to standard of care.
The composite endpoint consisted of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke.
Results also showed a 22% reduction in cardiovascular death with Victoza treatment compared with placebo, and reductions in non-fatal myocardial infarction and non-fatal stroke.
All-cause death was significantly reduced by 15% with Victoza compared with placebo. An expanded cardiovascular endpoint was also reduced by 12% with Victoza compared with placebo.
However while the results are very significant, they fell short of the expectations of investors, who had been hoping for a greater impact on cardiovascular outcomes. Novo's share price has fallen on the news, with expectations having been raised when top line results were announced earlier this year.
With sales of almost 4.6 billion Danish kroner (£505 million) in Q1 alone, Victoza is already a key drug for Novo – but the company hopes new data will help boost sales.
But the underwhelming results put Victoza at a disadvantage to Lilly and Boehringer Ingelheim's rival drug Jardiance (empagliflozin).
The oral treatment reduced the risk of CV death, non-fatal heart attack or non-fatal stroke by 14% versus placebo.
The risk of CV death was reduced by 38%, but with no significant difference in the risk of non-fatal heart attack or non-fatal stroke.
On Sunday the companies released new sub-analyses of data from Jardiance's EMPA-REG OUTCOME trail at the American Diabetes Association congress. It said these analyses showed the reduced risk of a heart attack or stroke applied to patients of all ages.
Novo Nordisk hopes that its next generation GLP-1 semaglutide can prove itself superior to all existing treatments, with pivotal data due out later this year. Semaglutide is a once-weekly injection, making it more convenient than the once-daily Victoza, though as a once daily pill, Jardiance may still be favoured by patients.
