FollowEuropean Medicines Agency adopted a ‘positive opinion’ and recommends the production of the Xultophy. The Novo Nordisk Xultophy has an active ingredient based on a combination of two ingredients, basal insulin and a glucagon-like peptide 1 (GLP-1) receptor agonist.
This is great news, but diabetics must be careful with their daily salt intake, as it may cause them cardiovascular problems more than compared with non-diabetics.
The Committee for Medicinal Products for Human Use stated that “The benefits with Xultophy are its clinically relevant effect on glycaemic control in patients with type 2 diabetes when used in combination with other oral glucose-lowering medicinal products. Xultophy has a neutral effect on body weight. The most common side effects are hypoglycaemia and gastrointestinal adverse reactions such as nausea and diarrhoea.”
Novo Nordisk Xultophy to be launched in 2015 in Europe
The Committee indicates Xultophy to be used when other drugs cannot manage the blood sugar levels anymore. The indication applies to both cases, when basal insulin is already used, as well as when it is not. Xultophy will provide a big change in the lives of diabetics. Trial research shows that the once a day injectable solution is more efficient in lowering blood sugar levels than any other drug. During June’s American Diabetes Association conference, data stemming from 52 weeks of research revealed that patients taking the combined drug had a 6.4 percent baseline blood glucose, compared to 6.1 and 7.1 when two separate Novo Nordisk drugs where administered.
The worldwide number of diabetics reached 382 million and will reach 592 million by 2035, according to the International Diabetes Federation’s prediction. The pharma companies will pay efforts to cover the growing market, but they usually face drawbacks when regulators insist on safety tests before approving new medication. Novo Nordisk allegedly spent $3.7 billion on diabetes R&D, according to Fiercebiotech.com. Sales of up to 1 $billion are expected for the first year after Xultophy is released. Xultophy is not expected to reach the U.S. market earlier than 2017, because one of the ingredients, Tresiba, was not accepted by regulators due to increased cardiovascular risks. Novo Nordisk will reapply after long-term data indicates improved results.
Xultophy, previously known as IDegLira, will probably be approved by the European Comission in the following three months, according to Reuters. Britain, Germany and Denmark will probably be the first markets where Novo Nordisk Xultophy will be released, according to Jakob Riis, executive vice president of marketing and medical affairs, Novo Nordisk.
