Takeda Pharmaceuticals and Lundbeck have jointly announced the submission of a New Drug Application (NDA) to the US FDA for the investigational agent vortioxetine. This drug is under investigation as an antidepressant for the treatment of major depressive disorder (MDD) in adult patients. It is thought to work through a combination of two complementary mechanisms of actions: receptor activity modulation and reuptake inhibition.
The NDA includes data from six short-term clinical trials, which involved 7,500 individuals and were conducted in regions throughout the world. The results from these trials statistically support the significant efficacy of vortioxetine in a dose range of 5 to 20mg per day.
MDD is very common, affecting approximately 121 million people worldwide, according to the World Health Organisation. The disease can be described as a complex syndrome of emotional, cognitive and somatic symptoms, which can be chronic or recurrent, and impact people both mentally and physically.
Azmi Nabulsi, M.D., M.P.H., president of Takeda Global Research & Development Center, Inc., stated, “The prevalence and complexity of major depressive disorder remains a growing concern for physicians and those living with the condition. This NDA submission is a critical milestone for Takeda and our partner Lundbeck, demonstrating our commitment to those living with and treating this condition. Together, we are focused on patients’ needs and believe that the profile of vortioxetine may translate into therapeutic benefits that help in the treatment of depression.”
Anders Gersel Pedersen, executive vice president and head of Research & Development at Lundbeck, added, “The vortioxetine NDA represents an important step in the evaluation of a potentially new treatment option for this debilitating disease. We look forward to working with the FDA as they review the data package.”
This submission marks a significant step forward in the development of new treatment options for MDD, highlighting the ongoing commitment of Takeda and Lundbeck to addressing the needs of patients suffering from this condition.
