FDA rejects Brintellix cognitive dysfunction claim

H. Lundbeck A/S (CSE:LUN) and Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) said FDA issued a complete response letter for an sNDA in which the partners sought to add an efficacy claim for Brintellix vortioxetine to treat cognitive dysfunction in adults with major depressive disorder (MDD). The partners market Brintellix in the U.S. to treat MDD in adults. ...