Takeda Pharmaceutical Company Limited and H. Lundbeck A/S recently announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental new drug application for review.
It will be used to add clinical data regarding the effect of Brintellix on certain aspects of cognitive function in adults with Major Depressive Disorder (MDD) to the current product label. Brintellix is currently approved and available in the United States for the treatment of MDD in adults. The FDA is expected to take action on this filing by March 28, 2016.
Depression includes a range of symptoms including cognitive ones. The cognitive symptoms of depression may go unrecognized by both health care providers and patients. Common cognitive complaints include difficulty concentrating, indecisiveness, trouble thinking and forgetfulness.
These symptoms are common and many of them often persist between major depressive episodes. According to a three-year prospective study of people treated for depression, cognitive symptoms were reported 94 percent of the time during major depressive episodes and 44 percent of the time between major depressive episodes (or during periods of partial remission).
“Cognitive symptoms are often present in patients suffering from MDD and reducing these symptoms can be challenging,” Dr. John Zajecka, an associate professor of psychiatry at Rush University Medical Center in Chicago, said.
