Novo's Victoza wins backing of FDA panel on CV benefit
- Danish drugmaker Novo Nordisk could soon see a regulatory boost to its top-selling type 2 diabetes drug Victoza (liraglutide) after an advisory panel to the Food and Drug Administration overwhelmingly agreed that the GLP-1 analog reduces cardiovascular risk.
- The Endocrinologic and Metabolic Drugs Advisory Committee voted 17 to 2 in favor that Novo's outcomes study LEADER established Victoza's cardiovascular benefit in type 2 diabetes patients.
- Novo submitted in October of last year a supplemental New Drug Application to include data from the trial on Victoza's label. A positive decision from the FDA is expected in the third quarter, although the FDA is not required to follow the advice of its advisory panels.
Proving cardiovascular benefit has become an important bar to clear for diabetes drugs, particularly as payers tighten the screws on drugmakers and pricing dynamics tighten.
In LEADER, Victoza cut the risk of major adverse cardiovascular events by 13%, a clear benefit but also less than investors had hoped for and just below the bar set by Eli Lilly and Boehringer Ingelheim's Jardiance (empagliflozin).
Vitcoza is a hugely important drug for Novo, accounting for 24% of its diabetes sales and 20% of overall revenues in the first quarter of 2017. Novo's reliance on Victoza, even as it grows new generation insulins like Tresiba (degludec), makes it crucial to maintain an edge over competition.
While Victoza remains the leader in the GLP-1 market, both its share and total prescription volume in the U.S. have fallen. Eli Lilly's rival Trulicity (dulaglutide) now accounts for 30% of the GLP-1 total prescription market share, still well below Victoza's 48% but climbing fast.
Sales of Trulicity totaled $373 million in the first quarter of 2017, up 160% from the same period a year ago. And Lilly executives believe the Trulicity brand strength among endocrinologists compares to Victoza, perhaps signaling further strength in the future.
A cardiovascular label could help Victoza preserve its edge and Novo Nordisk may get a huge lift later this year if the Food and Drug Administration approves its experimental oral GLP-1 semaglutide.
But it isn't just Victoza that has been causing Novo Nordisk some anxiety. The company has predicted just "modest sales growth" over 2017, cutting guidance and swapping out CEOs. Falling net prices for insulins and stiffer competition in diabetes could hurt the Danish drugmaker more than its peers, given its near exclusive focus on diabetes.
- Novo Nordisk Press release
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