FDA committee finds Brintellix effective for treating cognitive function problems related to adult depression
Brintellix is a product of Takeda Pharmaceutical Co. Limited, of Japan, and Danish-based pharmaceutical company H. Lundbeck.
Brintellix is an inhibitor of serotonin (5-HT) reuptake and an agonist at 5-HT1A receptors, a partial agonist at 5-HT1B receptors and an antagonist at 5-HT3, 5-HT1D and 5-HT7 receptors.
“(This) positive recommendation underscores the role of addressing the medical need of patients who experience cognitive dysfunction in depression,” Emiliangelo Ratti, head of the CNS therapeutic area unit at Takeda, said. “Common cognitive symptoms include difficulty concentrating, indecisiveness and trouble thinking. Many of these symptoms are prevalent during major depressive episodes and can have an impact on depressed patients.”
The committee's positive recommendation has been forwarded to the FDA. Brintellix came before the FDA for review this past August. A decision is expected by March 28.
“We are pleased with the advisory committee's recommendation that we have provided substantial evidence to support a claim of effectiveness of Brintellix for treating certain aspects of cognitive dysfunction in MDD,” Anders Pedersen, head of drug development at Lundbeck, said. “This positive vote underscores the value of the robust research we’ve conducted on cognitive symptoms, which we’ve pursued knowing that patients need options. We are pleased that this sNDA represents the first regulatory submission to the FDA on this topic, and we look forward to working with the agency as they complete their review.”
After being the subject of a three-year study, Brintellix was approved by the FDA for treatment of MDD in September 2013. To date, it has been approved for the treatment of MDD in 64 nations around the world.