- Medexus Pharmaceuticals (TSX:MDP) has announced on Monday (July 25) that it has resubmitted its new drug application for treosulfan to the US Food and Drug Administration
- The resubmission is in response to an FDA request to submit information to complete medac’s April 2022 NDA resubmission and initiate FDA review
- medac is a strategic partner of the Medexus Pharmaceuticals
- An FDA decision is expected within six months of acceptance
- A Phase 3 clinical trial of treosulfan previously met the primary endpoint and key secondary endpoints
- Shares of Medexusd Pharmaceuticals are up 4.78 per cent to C$2.19 as of 11:16 a.m. EDT on Monday
Medexus Pharmaceuticals (MDP) has resubmitted its new drug application (NDA) for treosulfan to the US Food and Drug Administration (FDA).
According to the company, the resubmission is in response to an FDA request to submit information in order to complete medac’s April 2022 NDA resubmission and begin an FDA review.
medac is a strategic partner of Medexus Pharmaceuticals.
The NDA approval requests of treosulfan is in combination with fludarabine as an introductory procedure for allogeneic hematopoietic stem cell transplantation, which is a procedure where patients receive healthy blood-forming cells from a donor to replace their own stem cells that have been damaged.
Medexus said in the press release that the current submission includes updates to data files and supporting information in response to the FDA’s information request. If the FDA accepts the response, it is expected a decision will be made within six months of acceptance.
“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,” Ken d’Entremont, CEO of Medexus, said in a press release. “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.”
d’Entremont continued, adding that an FDA approval would then lead to a commercial launch of treosulfan in the US in the first half of 2023.
Treosulfan is currently being used in treating eligible patients with acute myeloid leukemia and myelodysplastic syndromes.
Shares of Medexusd Pharmaceuticals are up 4.78 per cent to C$2.19 as of 11:16 a.m. EDT on Monday.