H. Lundbeck A/S (Lundbeck) and Takeda Pharmaceutical Company Limited (Takeda) jointly announced today the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for the investigational agent vortioxetine (formerly known as Lu AA21004) for the treatment of major depressive disorder (MDD) in adult patients.
Vortioxetine is under investigation as an antidepressant with multimodal activity that is thought to work through a combination of two mechanisms of actions: receptor activity modulation and re-uptake inhibition. The NDA includes data from six short-term placebo controlled studies, including one dedicated study in the elderly. The studies have been conducted in regions throughout the world and support statistically significant efficacy of vortioxetine in a dose range of 5–20mg per day. Efficacy of vortioxetine was also demonstrated in a long-term relapse-prevention study in major depression. The vortioxetine global clinical development program included more than 7,500 individuals exposed to the drug.
“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,” said Azmi Nabulsi, MD, MPH, president of Takeda Global Research & Development Center, Inc. “Together, we are focused on patients’ needs and believe that the multimodal activity profile of vortioxetine may translate into therapeutic benefits that help advance the treatment of depression.”
“We’re are encouraged by the 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,” said Anders Gersel Pedersen, Executive Vice President and Head of Research & Development at Lundbeck. “The NDA for vortioxetine 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.”
Within 75 days of submission, the FDA is expected to determine whether the NDA filing will be accepted for review. Acceptance of the filing will trigger a milestone payment from Takeda to Lundbeck.