The Management Board of Celon Pharma S.A. (the “Company”) hereby informs that on April 20, 2022 an application was submitted to the Food and Drug Administration (FDA) for the granting of the Breakthrough Designation to Falkieri (Celon's esketamine DPI) in treatment-resistant bipolar depression therapy.
This application is supported by results of pre-clinical and clinical trials, in particular the treatment-resistant bipolar depression phase II trial, in which the esketamine DPI developed by the Company has demonstrated an exceptional clinical benefit.
The Company anticipates that the American regulator's decision in that matter will be announced within approx. 60 days.
For Falkieri (Celon’s esketamine DPI), the procedure for granting the Breakthrough Designation would offer a number of advantages; regulatory, clinical and administrative facilitation for the applicant. It can significantly accelerate the market admission of this therapy in the US.
In the opinion of the Company's Management Board, assignment of the aforementioned status significantly increases the commercialization value of the project, and simultaneously minimizes the regulatory risk for the potential partner.