COPENHAGEN (Reuters) - Danish drugmaker Lundbeck has received marketing authorization from the European Commission for its antidepressant Brintellix following approval in the United States in September, it said on Friday.
Brintellix is important for Lundbeck, which hopes it will provide a new source of revenue as its existing antidepressant Cipralex - sold as Lexapro in the United States and Japan - comes off patent.
Cipralex is Lundbeck’s single biggest source of revenue.
The approval for Brintellix will cover all 28 European Union member states plus Iceland, Liechtenstein and Norway.
“Lundbeck expects to launch Brintellix in its first markets in the second half of 2014,” the company said in a statement.
The company had said in October that it expected a European launch in the first half of next year.
A Lundbeck spokesman said the later start was the result of a more conservative approach by the company in estimating the date but that nothing significant had changed since October.
“It is still possible that the launch will take place in the first half of 2014”, the spokesman said.
The U.S. Food and Drug Administration approved Brintellix in September and the EU decision had been expected after recommendations from the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) in October.
The drug will be co-marketed with Japan’s Takeda Pharmaceutical.
Reporting by Stine Jacobsen; Editing by Anthony Barker