Lilly's Cymbalta wins new approval for anxiety disorder

November 30, 2009

Eli Lilly and Co. announced Monday that it has won approval to market star drug Cymbalta for a new use, an event likely to boost sales of the medicine.

The U.S. Food and Drug Administration OK’d Cymbalta as a maintenance treatment for generalized anxiety disorder, which affects nearly 7 million Americans. Cymbalta was already approved to treat acute attacks of generalized anxiety disorder, but the approval as a maintenance therapy means patients can take the drug on a regular basis.

Many physicians have already been prescribing Cymbalta as a maintenance therapy for anxiety, but the FDA approval allows Lilly to specifically market Cymbalta for the new use.

Sales of Cymbalta, Lilly’s No. 2  selling drug, grew at a 13.6-percent clip through the first nine months of the year, and are on pace to top $3 billion for the year.

Lilly needs extra sales of Cymbalta to offset the looming loss of revenue when its cancer drug Evista and antipsychotic Zyprexa face competition from cheaper generics in 2010 and 2011, respectively.

Cymbalta, which was first approved as an antidepressant in 2004, is now also approved to treat diabetic neuropathy and fibromyalgia, all in adults.


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