Novo will make Tresiba available in all European Union countries, Katrine Rud von Sperling, a spokeswoman for the Bagsvaerd, Denmark-based company, said in e-mailed comments.
The “timing of the launch will be dependent on pricing and reimbursement negotiations, with expected first launches during the first half of 2013,” she wrote.
The once-a-day insulin Tresiba, also known as degludec, obtained the European Commission’s marketing authorization on Jan. 21. Novo’s Chief Scientific Officer Mads Krogsgaard Thomsen said in a Nov. 9 interview the company was planning for U.S. approval of the medicine for the first half this year, following the backing of an advisory panel to the Food and Drug Administration.
Novo will give an update on the U.S. regulatory process when it releases full-year results on Jan. 31, Rud von Sperling said.
In Japan, the medicine has been approved and Novo is negotiating a price with the authorities there, she said.
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