New Antidepressant OKd by FDA

Tuesday, 01 Oct 2013 12:32 PM

 

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H. Lundbeck A/S and Takeda Pharmaceutical Co. (4502) won approval for the drug Brintellix to treat people with major depressive disorder, U.S. regulators said.
Major depressive disorder is one of the most common mental disorders in the U.S. affecting about 7 percent of U.S. adults each year, according to the National Institutes of Health. The condition interferes with a person’s ability to work, sleep, study, eat and enjoy once-pleasurable activities.

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“Since medications affect everyone differently, it is important to have a variety of treatment options available for patients who suffer from depression,” Mitchell Mathis, acting director of the Division of Psychiatry Products in the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research, said in a statement.
Peak sales of the drug may reach $1 billion to $2 billion and Lundbeck plans to hire more than 200 salespeople in the U.S. to market the medication, Chief Financial Officer Anders Gotzsche said in an interview in August. Sales of Brintellix may help offset losses from Lundbeck’s Lexapro that began facing generic competition in 2012. Lexapro went from generating $474 million in sales in 2011 to an estimated $8 million this year.
Lundbeck, based in Copenhagen, will co-promote the drug with Osaka, Japan-based Takeda.
Generic drugs are available to treat depression as well as Eli Lilly & Co. (LLY)’s Cymbalta and AstraZeneca Plc (AZN)’s Seroquel XR.
 

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