LONDON A Novo Nordisk drug combining its long-acting insulin degludec with its type 2 diabetes treatment Victoza has been recommended for approval in Europe, in an important boost for the Danish company.
The European Medicines Agency said on Friday it had issued a positive opinion for Xultophy, previously known as IDegLira, implying the medicine is likely to be formally approved by the European Commission within three months.
Novo said it planned to launch Xultophy in the first European markets in the first half of 2015.
Jakob Riis, executive vice president of marketing and medical affairs at Novo Nordisk, said Britain, Germany and Denmark were likely to be among the first launch markets for the product.
Clinical trial results have shown that the once-daily injection lowers blood sugar more than each medicine taken on its own, setting a new standard for sugar control in diabetic patients.
Prospects for degludec - already on sale separately in Europe under the brand name Tresiba - and the new combination with Victoza are critical for Novo, which is the world’s biggest insulin maker.
Shares in Novo gained 1.6 percent on news of the favorable European decision, outperforming the European drugs sector which slid 0.3 percent by 1200 GMT (8:00 a.m. EDT).
Victoza has been a major growth driver for the group in the past few years but its sales are now rising more slowly, and Novo suffered a major setback in 2013 when U.S. regulators demanded more data on the safety of Tresiba before approving it.
With diabetes affecting 382 million people worldwide and the number of cases expected to rise to 592 million by 2035, according to the International Diabetes Federation, the disease represents a huge market for pharmaceutical companies.
Novo's main rivals in the space are Sanofi and Eli Lilly, which are also major suppliers of insulin.
Combination therapies for the growing type 2 diabetes health crisis are becoming increasingly common as patients continually require additional medicines as the disease progresses.
In addition to good blood sugar control, patients taking Xultophy also tend to lose weight. Weight loss is a particularly beneficial effect as obesity is a leading cause of type 2 diabetes and insulin tends to cause weight gain.
(Additional reporting by Ole Mikkelsen; Editing by David Holmes)