The European endorsement, announced by the London-based agency and the company last week, follows regulatory delays for the diabetes treatment in the United States, where the bulk of future sales are expected to be generated.
Tresiba, or degludec, is central to Novo’s aim of ending Sanofi’s dominance of the long-acting insulin market and the group said it expected to launch it in several European markets early next year, subject to final approval.
Diabetes is on the rise worldwide, fuelled by increased rates of type 2 diabetes, which is linked to obesity, making the disease a major target for drug company investment. The International Diabetes Federation estimates that 366 million people had diabetes in 2011 and it projects this figure will rise to 552 million by 2030.
Mads Krogsgaard Thomsen, Novo’s chief science officer, said he expected Tresiba to win over the majority of new patients, given its improved qualities and slow absorption rate, which provides a long-lasting and stable effect.
"Our ambition is that this product will be the biggest long-acting insulin in the market within the next eight to nine years," he told Danish television.
Novo, the world’s largest insulin maker, also won a green light for Ryzodeg, which combines degludec with insulin aspart, and this product is expected to go on sale around a year after Tresiba.
Recommendations for marketing approval by the European agency’s Committee for Medicinal Products for Human Use (CHMP) are normally endorsed by the European Commission within around two months.
The FDA said three months ago it was convening an advisory committee meeting on November 8 to assess Tresiba. It convenes such panels when it wants independent expert advice on scientific, technical and policy matters relating to new drugs.
Novo Nordisk News Release, Oct 24, 2012