Victoza superiority to Januvia made official by FDA
pharmafile | April 10, 2012 | News story | Medical Communications, Sales and Marketing | Januvia, Merck, Novo Nordisk, Victoza, diabetes
Novo Nordisk is now able to claim superiority for its diabetes drug Victoza compared to Merck’s rival treatment Januvia.
The US regulator has allowed the firm to update its label for Victoza (liraglutide), to include data showing superior blood sugar control and weight reduction compared to Januvia (sitagliptin).
The decision comes after a recent open-label trial that showed patients treated with two different doses of the injectable Victoza saw larger reductions in blood sugar than those treated with Merck’s Januvia pill.
Results showed that nearly twice as many patients on Victoza reached the American Diabetes Association (ADA) target of blood glucose levels of 7% or less when compared to Januvia.
“The data from these studies further demonstrate the strong clinical profile and the value of Victoza in the treatment of type II diabetes,” said chief science officer Mads Krogsgaard Thomsen.
Victoza received FDA approval in 2010 whilst Januvia has been on the market since 2006, and both are now fighting for market space in the highly competitive diabetes market.
The Januvia franchise has by the far the most sales – registering $4.9 billion in sales last year. But Victoza has been growing strongly, and saw 2011 sales of DKK 5.9 billion ($1 billion), a growth of 159% on the previous year.
The treatments are designed to lower blood sugar levels in type II diabetics, but work in different ways: Januvia is taken as a once-daily pill, whereas Victoza must be injected once a day, and works as a GLP-1 agonist.
Both are used when a patient’s blood sugar level has failed to be maintained on metformin or sulfonylurea alone.
But there are concerns that the treatments raise the risk of pancreatitis and other side effects, and both Merck and Novo must complete post-marketing studies to prove the drugs’ long-term safety.
The FDA censured Merck last month when the regulator said the firm had been dragging its heels over conducting these safety studies.
Injections versus tablets
Many diabetes patients want to delay the need for injections, but Novo hopes the efficacy of its drug will outweigh this inconvenience.
Novo does not have the injectable market to itself however – it is competing with Amylin’s once-weekly Byetta and its longer lasting Bydureon, which only requires an injection once a month.
Ben Adams
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