COPENHAGEN (Reuters) - Denmark’s Novo Nordisk, the world’s biggest insulin producer, said on Monday it got the final go-ahead from authorities to market its long-acting diabetes drug Tresiba in Europe.
Novo Nordisk said in a statement that the European Commission had granted marketing authorization for Tresiba and another insulin, Ryzodeg.
Novo Nordisk, the world’s biggest insulin producer, has estimated that Tresiba, the brand name for the active ingredient degludec, could become a blockbuster drug.
A drug reaches blockbuster status when it generates more than $1 billion in annual sales.
Novo Nordisk said it expected to launch Tresiba in Britain and Denmark in the first half of 2013 and in other European markets throughout the rest of this year and next. It will launch Ryzodeg about one year after Tresiba, it said.
“These marketing authorizations constitute significant milestones for Novo Nordisk and the treatment of diabetes,” Mads Krogsgaard Thomsen, Novo Nordisk’s chief science officer said in a statement.
Tresiba is central to Novo’s aim of ending rival Sanofi’s dominance of the long-acting insulin market.
It has already been approved by regulators in Japan and is awaiting approval from the U.S. Food and Drug Administration (FDA).
Last November, an advisory panel to the FDA voted to recommend approval of Tresiba, despite signals of possible cardiovascular risk.
The FDA rarely goes against its advisory panel’s recommendations when making its final decision.
Reporting by Mia Shanley; Editing by Helen Massy-Beresford