FDA Approves Symbyax for Treatment Resistant Depression

This has been a long battle for approval for the drug, and it has been prescribed, but this is the first time approved for depression. Lilly has also updated the Symbyax and Zyprexa labels to include additional information regarding weight gain, hyperglycemia, and hyperlipidemia for the side effects side. Instead of 2 pills, there’s a choice now for one combination if it meets the desired needs for the patient as determined by the physician. BD

Powerful drugs for schizophrenia and bipolar disorder are now available to treat depression, and the latest is a combo pill of Eli Lilly’s Zyprexa and Prozac called Symbyax.

Lilly said today that the FDA gave the green light to Symbyax after a difficult regulatory road. Symbyax has been on the market since 2003 as an approved treatment for bipolar depression, which are the down episodes associated with that disorder. Lilly has sought since 2006 to expand Symbyax’s reach to include treatment-resistant depression –- which it defines as failure to respond to two or more regular antidepressants -– but the FDA twice delayed approval for that use.

Lilly spokesman Jamaison Schuler told the Health Blog that the FDA had requested more data before acting, but he couldn’t say what kind. Zyprexa is Lilly’s best-selling antipsychotic, while Prozac is the iconic antidepressant.

Lilly touts Symbyax as the first drug for treatment-resistant depression, but Bristol-Myers Squibb’s Abilify, which is in the same class of medicines as Zyprexa, is already being sold as an “add-on” therapy for depression. The difference is that Abilify needs to be taken with an antidepressant, whereas Symbyax can be taken alone because it combines an antipsychotic and antidepressant in one pill. Bristol-Myers spokeswoman Sonia Choi says Abilify’s studies looked at patients who had had inadequate responses to one antidepressant.