Lundbeck and partner Takeda Pharmaceutical Co are planning to file a new antidepressant in the coming months on the back of positive late-stage data.
The Danish drugmaker announced positive top-line results from three recently-completed Phase III studies of Lu AA21004, for the treatment of adults with major depressive disorder using dosages from 10 to 20mg. The data from the three studies showed that the drug statistically significantly reduced depression symptoms in patients with MDD compared to placebo.
In total, out of the ten large, placebo-controlled studies of Lu AA21004 completed in patients with MDD, eight have shown effect. Further analysis is ongoing and data are expected to be presented at upcoming medical conferences, Lundbeck said.
Based on the current data, Lundbeck and Takeda plan to submit a New Drug Application to the US Food and Drug Administration during the second half of 2012. The Copenhagen-based company will file the drug in Europe and Canada during the second half as well.
The news pushed the stock up significantly a fortnight after Lundbeck revealed its earnings slumped as a result of generic competition to its flagship antidepressant Cipralex/Lexapro (escitalopram).