Lilly, Forest get new FDA indications

Two new indications for psychotropic meds today: Eli Lilly got the FDA nod for its Prozac-and-Zyprexa combo for use against treatment-resistant depression and two other uses, and Forest Laboratories won an indication for Lexapro use in adolescents.

The Lilly combo drug, Symbyax, is now the first drug FDA-approved for treatment-resistant major despressive disorder. And Zyprexa and Prozac got the FDA's approval as treatments--in separate pills--for acute bipolar depression and treatment-resistant depression. Lilly said it updated Symbyax's label to include the risk of weight gain and hyperglycemia that has dogged Zyprexa (and resulted in thousands of lawsuits). The drug was initially approved in 2003 to treat bipolar depression.

"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."

Lexapro, meanwhile, has been approved to treat major depression in people aged 12-17, Forest said in a release. An SSRI (selective serotonin reuptake inhibitor), it was originally approved for adults in 2002. The new indication was supported by two placebo-controlled studies.

Ironically, the new indication follows the Justice Department's allegations last month that the company promoted Lexapro for off-label use in children. Forest has denied the charges.

- read the Lilly release
- check out Forest's release
- see the Symbyax story at RTT News
- check out the Lexapro article from HealthDay