Following its initial review of a supplemental new drug application for Lexapro (excitalopram oxalate) in social anxiety disorder, the FDA has determined the application not approvable and has informed Forest of its decision in a non-approvable letter.
While indicating that data from one of the two required pivotal studies supported the application, the agency raised questions related to the reliability of patient data at one study center in the second study.
By eliminating the European study center in question, the statistical significance of the study declined to a point the FDA could no longer accept it as a positive pivotal study.
Forest is now reviewing the FDA’s analysis and will determine the appropriate next steps to address the non-approvable letter in the coming months. This may include additional discussions with the FDA pertaining to data from the excluded center or conducting an additional pivotal study.
Lexapro is indicated for the initial and maintenance treatment of major depressive disorder and for generalized anxiety disorder in adults. It is also approved in Europe, where it is marketed by H Lundbeck A/S, for depression, social anxiety disorder and panic disorder.