Novo Nordisk's insulin, Tresiba, close to European approval
A new insulin, currently under review in the United States, recently was recommended for approval in Europe.
The European Medicines Agency, a European Union advisory panel, gave the green light to Novo Nordisk's Tresiba, or insulin degludec, Bloomberg reported. The European Commission typically follows the EMA's recommendation.
If given final approval, the Denmark-based insulin maker plans to launch Tresiba in several European markets early next year.
With its new insulin, Novo Nordisk would take on its competitor Sanofi's Lantus, which controls about 80 percent of the market, the Chicago Tribune explained. Novo describes its higher-strength formulation as longer acting and more flexible in terms of dosing than Lantus.
Mads Krogsgaard Thomsen, Novo's chief science officer, said he expected Tresiba to garner a large portion of the market share, claiming that the product's improved qualities and slow absorption rate deliver an enduring, stable result.
"Our ambition is that this product will be the biggest long-acting insulin in the market within the next eight to nine years," he added.
As for sales of Tresiba in the States, the US Food and Drug Administration has scheduled a Nov. 8 advisory committee meeting of independent industry experts to evaluate Novo Nordisk's new insulin.
Despite Tresiba being recommended for approval in Europe and receiving approval in Japan in September, the FDA still could require additional data or analysis before it makes a final ruling.
"Assuming no further delays in the U.S., Novo should have Tresiba approved in the U.S., Europe and Japan during the first quarter of 2013," said Lars Hevreng, an analyst with SEB Enskilda in Stockholm, according to Bloomberg.
Pharmaceutical companies are investing in diabetes because of the increase in the number of individuals with it worldwide. According to the International Diabetes Foundation, by 2030, that number could reach an estimated 552 million, up from 366 million in 2011, The Baltimore Sun noted.
"Novo Nordisk wins EU agency backing for new insulin," chicagotribune.com, October 19, 2012, Ben Hirschler and Mette Fraende
"Novo Nordisk Wins EU Panel's Recommendation for Tresiba," bloomberg.com, October 19, 2012, Albertina Torsoli
"UPDATE 2 -- Novo Nordisk wins EU agency backing for new insulin," baltimoresun.com, October 19, 2012, Ben Hirschler and Mette Fraende