New bipolar disorder drug approved by FDA

Eli Lilly Says It Wins FDA Approval for New Drug to Treat Depressive Phase of Bipolar Disorder


Eli Lilly and Co. on Monday said it has won regulatory approval to sell its new drug Symbyax to treat the depressive phase of bipolar disorder.


The U.S. Food and Drug Administration approved the drug, which is a combination of the active ingredients in two other drugs the anti-depressant Prozac and the anti-psychotic Zyprexa, which is used for treating manic stages of bipolar disorder.



Symbyax treats the depression stages of the illness without triggering mania, said Marni Lemons, a spokeswoman for the Indianapolis-based drug company.



'It's always been very challenging for physicians to treat the depressed phase without sending people with bipolar disorder from the depressed phase right into the manic phase,' Lemons said.



Symbyax will be available to physicians by mid- to late-January, Lemons said.



Some patients may be able to take Symbyax for the depressive stages of bipolar disorder and Zyprexa for the manic phases, she said.



Hemant K. Shah, an independent analyst from Warren, N.J., said the new drug would be 'incrementally important' for Eli Lilly.



'I'm not sure that this is going to be a big blockbuster by itself, but it will add it's ability to Zyprexa,' Shah said.



An estimated 2.5 million Americans have bipolar disorder, although some say the number is as high as 10 million.



Shah pointed out that 'that's a relatively narrow population.'



Lemons said Symbyax works faster than other drugs used to treat depression. That would be important because patients in bipolar disorder's depression stages are particularly prone to suicide attempts, she said.



'Traditional (antidepressants) like Prozac take several weeks to work,' Lemons said, adding that patients taking Symbyax can see results in about a week.



Lemons said she did not know the exact price of the drug, but said it would be comparable to Zyprexa.



Shares of Eli Lilly rose $1.00, or 1.4 percent, to close at $71.62 on the New York Stock Exchange.


View drug information on Prozac Weekly; Zyprexa.