Medac resubmits treosulfan NDA to FDA, says Medexus Pharmaceuticals
Medexus Pharmaceuticals said that its strategic partner medac has resubmitted the new drug application (NDA) for treosulfan with the US Food and Drug Administration (FDA).
Treosulfan is part of a preparative regimen for allogeneic hematopoietic stem cell transplantation (allo-HSCT). It is intended to be used in combination with fludarabine for the treatment of eligible patients having acute myeloid leukemia and myelodysplastic syndromes.
According to Medexus Pharmaceuticals, the current submission of the NDA was a response to the request from the pharma regulator to submit information to complete the April 2022 NDA resubmission of medac and initiate a review by the FDA.
Medac resubmits treosulfan NDA to FDA, says Medexus Pharmaceuticals. Photo courtesy of Tobias Kuhardt/Wikipedia.org.
The current submission of treosulfan NDA covers updates to data files and associated information in response to the regulator’s information request.
FDA’s decision on treosulfan NDA is likely to be taken within six months of its acceptance.
Ken d’Entremont — Medexus Pharmaceuticals CEO said: “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.
“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.”
Treosulfan has approval from Health Canada and is sold in Canada as Trecondyv.