FDA accepts sNDA for review of Takeda and Lundbeck’s brintellix in MDD patients

Brintellix was discovered by Lundbeck researchers and the clinical trial program in the US was conducted jointly by the two firms, while Takeda holds the NDA for the US market.

Currently, brintellix is approved and available in the US for the treatment of MDD in adults. The drug is a trademark of Lundbeck and is used under license by Takeda Pharmaceuticals USA.

The company noted that the FDA is expected to take action on this filing by 28 March next year.

Rush University Medical Center Associate Professor of Psychiatry John Zajecka said: "Cognitive symptoms are often present in patients suffering from MDD and reducing these symptoms can be challenging.

"Many patients continue to experience certain cognitive and other symptoms even after improvement in their MDD."

Takeda US Medical Affairs vice-president Charlie Baum said: "If approved by the FDA, Brintellix would be the first treatment for MDD to include clinical trial data showing an effect on certain aspects of cognitive function in the US label.

"We look forward to working with the Agency as it considers this important need for patients with MDD."

The sNDA is based on the FOCUS and CONNECT trials, which were specifically designed to evaluate the effect of Brintellix on certain aspects of cognitive function in adult patients with MDD using objective measures of cognitive function.

The two 8-week, randomized, double-blind, placebo-controlled trials of Brintellix 10 and 20mg/day used a well-established neuropsychological test called the Digit Symbol Substitution Test (DSST).