Novo Nordisk plans to take the private route to market in the UK for the launch of Saxenda, its high-dose version of the diabetes blockbuster Victoza which many observers believe will be a game-changer for obesity.
In September, a US Food and Drug Administration advisory panel voted 14-1 in favour of Saxenda (liraglutide 3mg), a once-daily human glucagon-like peptide-1 (GLP-1) analogue for obesity. The dose for diabetes is Victoza 1.2mg and 1.8mg.
The Danish firm has just presented data from the third and largest of its Phase III programme involving 3,731 obese patients. The results showed that 92% of participants on Saxenda lost weight compared to 62% on diet and exercise alone. Patients who completed the 56-week study enjoyed 9.2% weight loss, compared to 3.5% on placebo.
Also, weight loss associated with liraglutide 3mg was accompanied by improvements in health-related quality of life as measured by three different questionnaires. Trial investigator Ken Fujioka, noted that “obesity is more than a disease of excess weight and patients may experience increased physical and mental health problems, as well as a reduced quality of life”.
Not seeking reimbursement in other EU states
It all looks promising for Saxenda and as preparations are made to hit the market, Jerzy Gruhn, head of Novo’s European division, told PharmaTimes in an interview in Copenhagen that in the UK it will “most probably be a private market launch.” The decision not to ask for reimbursement has been taken “because it is the easiest way to offer that option for obesity patients”.
When asked whether a similar strategy would be seen across Europe, Mr Gruhn noted that Novo is looking at a number of markets across the continent for private launches and “the UK will not stand out” as an exception. Launches are expected next year.
That Novo sees obesity as an important area was made clear after it unveiled plans in September for a new research unit looking at the disease in Seattle. It will initially employ 10 people, rising to 60 by the end of 2016, and some 300 employees worldwide are working within obesity R&D at Novo Nordisk.
Mr Gruhn noted that there is a growing understanding that obesity is not something people brought on themselves and that it is a serious problem for society and individuals.
As for Tresiba (insulin degludec), Novo’s new-generation, long-acting insulin, Mr Gruhn confirmed that before refiling in the USA, the company is waiting for more information from the DEVOTE study, a cardiovascular outcomes trial demanded by the Food and Drug Administration which rejected Tresiba in February 2013.
Tackling slow take-up of Tresiba in UK
As for Europe, in the countries where Tresiba is getting reimbursed, “we are getting really good results and Switzerland and Germany are doing really well. He added that “being a patient with diabetes (Mr Gruhn was diagnosed with type 1 aged 38) I am quite happy that I live in Zurich”.
He told PharmaTimes that “the penetration in the UK is not growing as fast as elsewhere but it is progressing”. Mr Gruhn argued that “the UK is pretty well-known for relatively small uptake of any new products” but it is still a key market, “though we need to be patient”.
This week has also seen the launch in the UK of NovoRapid PumpCart, the first prefilled pump cartridge with an insulin analogue that has been specifically designed for insulin pumps. The cartridge was developed in tandem with Roche.
He was unwilling to say that patients in the UK are suffering by missing out on innovative drugs, but “it is critically important to us that all patients across Europe get access to the most modern therapies”.