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Diabetes drug approved
Source: Agencies |
July 4, 2009, Saturday
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DANISH pharmaceuticals group Novo Nordisk's diabetes drug Victoza, a key driver for future sales, has won European Commission approval for marketing across the European Union, the company said yesterday.
The move was expected, following a positive opinion from the European Medicines Agency on April 23.
"The European Commission has granted marketing authorization for Victoza for the treatment of type 2 diabetes in adults," Novo Nordisk said in a statement, calling it an "important milestone."
The company will launch Victoza -- which is the brand name for liraglutide -- in Britain, Germany and Denmark this summer and in other European markets in the second half of 2009 and throughout 2010, Novo Nordisk said.
"The marketing approval in Europe does not change Novo Nordisk's expectations for the company's financial results for 2009," it added.
The company will give an updated outlook for its full-year 2009 financial results when it publishes first-half figures on August 6.
Victoza is the firm's most important new drug. Its prospects, however, have been clouded because some experts have questioned its safety.
A United States advisory panel handed down a split ruling on whether Victoza was safe enough to come to the market. The US Food and Drug Administration's outside experts voted 6-6 when asked if thyroid tumors found in tests of rats and mice should prevent sales of the drug. There was one abstention.
The move was expected, following a positive opinion from the European Medicines Agency on April 23.
"The European Commission has granted marketing authorization for Victoza for the treatment of type 2 diabetes in adults," Novo Nordisk said in a statement, calling it an "important milestone."
The company will launch Victoza -- which is the brand name for liraglutide -- in Britain, Germany and Denmark this summer and in other European markets in the second half of 2009 and throughout 2010, Novo Nordisk said.
"The marketing approval in Europe does not change Novo Nordisk's expectations for the company's financial results for 2009," it added.
The company will give an updated outlook for its full-year 2009 financial results when it publishes first-half figures on August 6.
Victoza is the firm's most important new drug. Its prospects, however, have been clouded because some experts have questioned its safety.
A United States advisory panel handed down a split ruling on whether Victoza was safe enough to come to the market. The US Food and Drug Administration's outside experts voted 6-6 when asked if thyroid tumors found in tests of rats and mice should prevent sales of the drug. There was one abstention.
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