Novo Nordisk has filed for approval of its combination product based on insulin degludec and insulin aspart in Japan as it continues its assault on the ultra-long-acting insulin market.
The combination product - referred to as DegludecPlus in Europe - is part of a franchise that Novo Nordisk is positioning to challenge the dominance of Sanofi's Lantus (insulin glargine) in the diabetes category. Lantus brought in sales of€3.92bn ($5.2bn) last year and is the world's top-selling insulin product.
The combination product combines insulin degludec - a new ultra-long-acting insulin analogue that is currently under regulatory review in Europe, the US and Japan - with Novo Nordisk's fast-acting NovoRapid product, which had revenues of 12.8 billion krone ($2.3bn) last year.
One of the advantages of insulin degludec is that it can be administered at any time of day to fit in with the needs of the patient, and that flexibility has led to speculation that in time it could overtake Lantus and become the top insulin product worldwide with multibillion dollar sales.
Novo Nordisk launched another long-acting insulin called Levemir a few years ago but this has not been able to match Lantus' growth trajectory.
The Japanese marketing application is based on results of the BOOST clinical programme, which involved nearly 3,000 type 1 and type 2 diabetes patients and showed improved blood glucose control compared to Lantus, as well as reductions in the rate of hypoglycaemia episode during the night compared to biphasic insulin aspart.
Novo Nordisk is planning to develop a series of combination products based on insulin degludec. Last year, it started phase III trials of a combination product based on insulin degludec and GLP-1 analogue liraglutide - the active ingredient in its Victoza product.
The pharma company is claiming to be further ahead with this programme than a Sanofi follow-up to Lantus which combines insulin glargine with GLP-1 analogue lixisenatide, which will be marketed as Lyxumia if it is approved.