Lilly wins FDA approval for expanded indication of depression drug

Eli Lilly and Company has reported that the FDA has approved a new indication for Symbyax. Symbyax is now reported to be the first drug approved by the FDA for the acute treatment of treatment-resistant depression.

The new Symbyax treatment-resistant depression (TRD) indication is for acute treatment of adult patients with major depressive disorder who have not responded to two separate trials of different antidepressants of adequate dose and duration in their current episode.

In other actions, the FDA also approved two new combination indications for Zyprexa (olanzapine) and fluoxetine for the acute treatment of bipolar depression and TRD. Lilly originally developed Prozac (fluoxetine HCl), the branded version of fluoxetine.

With these FDA approvals, clinicians in the US have the choice to use the single pill option (Symbyax), or the two drugs (Zyprexa and fluoxetine) together, allowing physicians to tailor treatment to each patient’s needs, said Lilly.

In addition to the new indications, Lilly has updated the Symbyax and Zyprexa labels to include additional information regarding weight gain, hyperglycemia, and hyperlipidemia following the FDA’s review of clinical trial data that Lilly submitted to the FDA between August 2007 and July 2008.

Cherri Miner, Lilly’s neuroscience senior medical director, said: Today’s new indications confirm that these medications are valuable tools for patients in the fight against severe and disabling mental illness, and expand treatment options for prescribers and patients.