Takeda Pharmaceutical Company and H. Lundbeck have submitted a new drug application (NDA) to the FDA for vortioxetine (Lu AA21004), an investigational drug for the treatment of major depressive disorder (MDD).
Vortioxetine is under investigation as an antidepressant with multimodal activity that is thought to work through receptor activity modulation and reuptake inhibition.
Takeda Global Research & Development Center president Azmi Nabulsi said the NDA submission is a critical milestone for Takeda and Lundbeck.
"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," Nabulsi added.
The application includes data from six short-term placebo controlled studies, including one study in the elderly, which support statistically significant efficacy of vortioxetine in a dose range of 5mg to 20mg per day.
A long-term relapse-prevention study in MDD has demonstrated the efficacy of vortioxetine.
Lundbeck research and development head and executive vice president Anders Gersel Pedersen said, "We are encouraged by the data results that indicate the potential for vortioxetine, if approved, to help address the needs of people suffering from major depressive disorder who are seeking additional therapeutic options."
