COPENHAGEN Sep 3 Danish group Novo Nordisk
, the world's biggest insulin producer, could see its
insulin degludec launched in Japan this year, analysts at Nordea
said, after the product passed an initial review in the
The First Committee on Drugs of Japan's Pharmaceutical
Affairs on Friday passed the review of degludec on Friday.
That meant the long-acting insulin, expected to be launched
under the name Tresiba, could also be approved both in the
European Union and the United States, Nordea said in a note to
"After subsequent price negotiations, a launch could take
place in 2012, in our view ... we have assumed a launch in Japan
in 2013," Nordea said.
The First Committee on Drugs serves as an advisory body to
the Ministry of Health, Labour and Welfare, and the remaining
step in the regulatory process will be an official approval from
the ministry, Novo Nordisk said.
"We think there is very good read-across to both EU and the
U.S. regulatory processes," Nordea said.
It said it expected to receive marketing authorisation from
the ministry within a few months and insulin degludec would be
launched shortly after completion of subsequent price talks.
(Reporting by Mette Fraende; Editing by Dan Lalor)