Novo Nordisk has presented yet more positive data which shows that switching patients to the Danish drugmaker’s new diabetes drug Victoza from Amylin/Eli Lilly’s Byetta results in better blood sugar control.
The data, which comes from the 14-week extension of the LEAD 6 Phase IIIb study, showed that patients switched to a once-daily injection of Victoza (liraglutide), a human glucagon-like peptide-1 (GLP-1) analogue from two daily jabs of Byetta (exenatide), the well-established drug in the GLP-1 class, experienced a statistically significant improvement in blood sugar control. The findings were presented at the European Association for the Study of Diabetes meeting in Vienna.
Other benefits associated with the switch included additional reductions in weight and systolic blood pressure. The study also showed that patients experience less nausea with Victoza over time.
The data comes a week after Novo was told by the US Food and Drug Administration that a decision on approval for liraglutide, has been deferred until the fourth quarter of 2009. Chief scientific officer Mads Krogsgaard Thomsen said that “we are in a constructive dialogue with the FDA” and most analysts seem to share his confidence that the green light is likely.
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 6-6 in April (with one abstention) as to whether data on thyroid tumours seen in studies on rodents permit approvability of the drug. Prof Thomsen told PharmaTimes World News at a Novo meeting recently in Copenhagen that over 40 clinical studies involving more than 6,800 people, of which more than 4,600 were treated with liraglutide, have revealed no significant evidence of any thyroid cancer link.
Victoza was approved in Europe in July to be used in combination with metformin and/or a sulphonylurea, or in combination with metformin and a thiazolidinedione, in patients who achieve insufficient glycaemic control with specified prior therapies. Prof Thomsen noted that initial feedback from physicians in the UK and Germany has been extremely positive and he is enthusiastic about the whole data package from the LEAD programme.
Approval in the USA will be key especially ahead of a long-acting (once-a week) version of Byetta which is also being reviewed. However Novo believes in the superiority of its product, certainly compared with twice-a-day exenatide (as shown in LEAD 6) and speaking at the Copenhagen meeting, Lotte Bjerre Knudsen, senior principal scientist at Novo and known as “the mother of liraglutide”, noted that Victoza has a greater homology to native human GLP-1 than exenatide (97% similarity compared to 53%).
Prof Thomsen told PharmaTimes World News that Novo’s plans for a successful launch in the USA are pretty much in place, noting that having principally dealt with diabetes specialists in the past, “we will now be going down the primary care route” to push liraglutide on the path to blockbuster status.
