Eli Lilly and Co. won U.S. approval for its drug Symbyax as a medicine for treatment-resistant depression, the company announced today.
The U.S. Food and Drug Administration OK’d Symbyax as the first drug for the acute treatment of treatment-resistant depression. So-called TRD is depression that has not improved when treated by two other antidepressants.
Symbyax is a combination of Lilly’s drugs Zyprexa and Prozac in one pill. It was approved by the FDA to treat bipolar depression in 2003.
Symbyax has about $75 million annual sales, a tiny portion of Lilly’s 2008 sales of $20.4 billion.
Wall Street analysts don’t expect Symbyax sales to grow much in the next few years. Tony Butler of Barclays Capital predicted in a December report that Symbyax sales would top out at $81 million in 2010, the year before Zyprexa’s patents expire, and then decline from there.
About 21 million American adults, slightly fewer than 10 percent of the population, suffer from depressive illnesses each year, Bloomberg News reported, citing the National Institute of Mental Health.
"Living with major depressive disorder is difficult and distressing for anyone, but even more so for patients whose symptoms continue despite treatment," said Lilly Medical Director Dr. Sara Corya in a statement. “Now, after two failed attempts with other antidepressants, doctors and patients have a new treatment option."
Lilly waited two years for the FDA’s approval because the agency wanted stronger language in the drug’s label about the risk of weight gain and diabetes, Bloomberg News reported. Lilly said it now has updated Symbyax’s label.
In a related action, the FDA said doctors could prescribe Zyprexa and Prozac, in separate pills, to treat bipolar depression and treatment-resistant depression.
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