Eli Lilly, on Monday, received approval to market its bipolar disorder treatment Symbyax-a combination of the antipsychotic Zyprexa and the antidepressant Prozac-to patients suffering from treatment-resistant depression (TRD). Symbyax becomes the first drug approved for TRD.

Symbyax was approved as a bipolar treatment in 2003, and Lilly has been trying diligently to expand its indications to patients with that haven’t responded to traditional drug therapies. 

“We define treatment-resistant depression patients as people who fail to respond to at least two different anti-depressants in their current episode of depression,” said Sara Corya, medical director at Eli Lilly. “You can imagine, that a patient at that stage is thinking that nothing is going to work for them. Those are the folks that we feel will be appropriate for Symbyax.”

Since it first filed a Supplemental New Drug Application (SNDA) for Symbyax in 2006, Lilly has spent enormous amounts of time and money trying to get the new. FDA twice delayed the drug, requesting further studies and data. 

Lilly spokesperson Jamaison Schuler, however, told 

 that FDA’s concerns weren’t about the efficacy data of Symbyax, but for long-term data on Zyprexa. 

At the same time Lilly was seeking expanded indications for Symbyax, it was also trying to add bipolar disorder indications to the Zyprexa and Prozac labels. 

Lilly said that it appears as if FDA delayed approval and lumped everything together. “It took a little longer than the natural progression,” Schuler said on Wednesday. “But I wouldn’t say this a natural progression considering how much was bundled into this decision.”

FDA also gave the OK for Lilly to promote Zyprexa and Prozac together, but as separate pills, for the same indication as Symbyax. This offers physicians and patients more dosage options.

“We designed Symbyax with some flexibility, so that you can raise one component without decreasing the other,” Corya told 

. “However, there are far more doses available for the individual components of the combo drug. While a lot of customers like the idea of taking one treatment from a compliance and ease-of-use perspective, the psychiatrists want to get into the nuance of the milligram dose.”

Lilly would not comment as to whether the current marketing strategy for any of the drugs would change because of the new indication. Prozac is currently not under patent and Zyprexa’s patent expires in October of 2011.

News Analysis

After repeated requests for additional study information, the wait has paid off: Lilly was approved to sell its bipolar drug Symbyax for treatment-resistant depression.

Pharmaceutical Executive-03-25-2009