Medexus Pharmaceuticals announces resubmission of Treosulfan NDA

Medexus Pharmaceuticals and medac announces that medac has resubmitted its New Drug Application for treosulfan with the U.S. Food and Drug Administration. The current submission was a response to the FDA request to submit information to complete medac's April 2022 NDA resubmission and initiate FDA review. The NDA requests approval of treosulfan in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation. The current submission includes updates to data files and supporting information in response to the FDA's information request received with the FDA's acknowledgment of receipt of the NDA resubmission in May 2022. If the response is considered complete by the FDA, the review clock for the NDA resubmission will then start as of the date of submission of a complete response. "We remain excited about the prospect of a treosulfan approval in the United States and about treosulfan's significant potential in the U.S. market," commented Ken d'Entremont, Medexus's CEO. "We are encouraged by the recent publication of the final study results and analysis of the pivotal phase 3 clinical trial of treosulfan conducted by medac, which met its primary endpoint and key secondary endpoints. An FDA approval within a two- to six-month period from the acceptance date would then pave the way for a commercial launch of treosulfan in the United States in the first half of calendar year 2023."