Takeda Pharmaceutical Company issued the following announcement on May 2.
Takeda Pharmaceutical Company Limited (Takeda; TSE: 4502) and H. Lundbeck A/S (Lundbeck; LUN.CO, LUN DC, HLUYY) today announced the U.S. Food and Drug Administration (FDA) approved a supplemental new drug application for TRINTELLIX® (vortioxetine). TRINTELLIX is the first FDA-approved treatment for MDD where the U.S. labelling now includes data from the largest replicated clinical studies on an important aspect of cognitive function in acute major depressive disorder (MDD, depression). The FOCUS and CONNECT studies showed TRINTELLIX had a positive effect on processing speed, an important aspect of cognitive function that may be impaired in adult patients with acute MDD.
FOCUS and CONNECT, two eight-week, randomized, double-blind, placebo-controlled studies, were conducted to evaluate the effect of TRINTELLIX on the Digit Symbol Substitution Test (DSST) during the treatment of acute MDD. The DSST is a neuropsychological test that most specifically measures processing speed, an aspect of cognitive function that may be impaired in MDD. The effects observed on DSST may reflect improvement in depression. Comparative studies have not been conducted to demonstrate a therapeutic advantage over other antidepressants on the DSST.
“Many of my MDD patients recognize the mood and physical attributes of depression, but do not often recognize that their cognitive symptoms may also be part of their depression. As part of a comprehensive treatment approach, it’s important for clinicians to talk to patients about all symptoms associated with depression. This updated TRINTELLIX labelling regarding improvement in processing speed provides important information to improve discussions between healthcare providers and patients about their depression,” said Dr. Gregory Mattingly, Associate Clinical Professor, Department of Psychiatry, Washington University School of Medicine.
Depression is a complex disorder that is more than just sadness. This condition has a wide range of symptoms, including depressed mood or loss of interest, physical symptoms such as sleep problems, decrease or increase in appetite, significant weight loss when not dieting or weight gain, and cognitive symptoms, like difficulty concentrating or slowed thinking. The prevalence of cognitive impairment associated with MDD is high.
“With my depression, I felt like my thoughts slowed down. It was as if my brain just couldn’t keep up. After speaking with my doctor, I was surprised to learn that this could be part of my depression,” said David, a patient who spoke about his experience with depression at a FDA Advisory Committee Meeting in 2016.
“Years of research, including the FOCUS and CONNECT studies, have helped us better understand how complex and debilitating depression can be for people and reinforces how important innovation is in bringing potential options to those suffering from depression,” said Anders Gersel Pedersen, Executive Vice President, Head of Drug Development, Lundbeck.
“We are pleased with the FDA’s approval of our sNDA to include data on an important aspect of cognitive function in MDD in the U.S. labelling of TRINTELLIX. The FOCUS and CONNECT data provides additional clinical information to healthcare professionals for people suffering from depression,” said Emiliangelo Ratti, Senior Vice President, Head of Neuroscience Therapeutic Area Unit, Takeda.
The FDA approved TRINTELLIX on September 30, 2013 for the treatment of MDD in adults. Vortioxetine is furthermore approved in 77 countries (including Europe, Canada, Chile, China, Mexico, Argentina, South Korea, Turkey, Australia, Hong Kong, Singapore and South Africa). It is available in more than 60 countries to date.
About Major Depressive Disorder (MDD)
MDD is a complex mental health illness that affects approximately 14 million people annually. Also known as clinical depression, MDD is the leading cause of disability worldwide and a major contributor to the overall global burden of disease. MDD may trigger emotional, cognitive and physical symptoms, which includes depressed mood, loss of interest or pleasure, significant weight loss or gain or change in appetite, insomnia or hypersomnia, psychomotor agitation or retardation, fatigue or loss of energy, feelings of worthlessness or excessive guilt, diminished ability to think or concentrate, or indecisiveness, and recurrent suicidal ideation.
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