CA - Medexus sees over a year's delay for medac to provide data requested by FDA for treosulfan

Medexus Pharmaceuticals ( OTCQX:MEDXF ) said it expects it will take its German partner medac up to a year or more to collect and submit the information requested by the U.S. Food and Drug Administration (FDA) for their therapy treosulfan.

Medac had resubmitted a new drug application (NDA) to the FDA for treosulfan in July 2022 but the agency had issued a second notice of incomplete response citing some issues to medac in September 2022.

The NDA was seeking approval for treosulfan in combination with fludarabine as a preparative regimen for patients with certain types of cancer undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT).

Medexus said on Thursday the FDA continues to seek supporting information from medac relating to a phase 3 trial of treosulfan conducted by medac.

Medexus added that based on its assessment of the FDA's feedback and discussions with medac, it now expects that it will take medac up to a year or more to collect and submit the information requested by the FDA. The FDA will then evaluate the information and, if complete, will then proceed to review medac's NDA resubmission.

FDA has made it clear that it will not progress unless medac collects the supporting information and responds to the FDA's remaining requests, Medexus noted.

Medexus said it has urged medac to respond to the FDA's requests and fulfill medac's obligations under the terms of the treosulfan license agreement to pursue all commercially viable paths to complete the NDA resubmission.

Medexus had reported this information along with its preliminary revenue results for FQ3.

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