TORONTO and CHICAGO, Nov. 01, 2021 (GLOBE NEWSWIRE) -- Medexus Pharmaceuticals Inc. (“Medexus” or the “Company”) (TSX: MDP) (OTCQX: MEDXF) and medac GmbH (“medac”) today announced that the U.S. Food and Drug Administration (“FDA”) has granted a Type A meeting to medac for treosulfan, a bifunctional alkylating agent developed for use as part of a conditioning treatment for patients prior to undergoing allogeneic hematopoietic stem cell transplantation. The Type A Meeting has been scheduled to occur on November 23, 2021.
On August 3, 2021, Medexus announced that it had received notice from medac, its licensor for treosulfan, that medac had received a Complete Response Letter (“CRL”) from the FDA with respect to the New Drug Application for use of treosulfan in the United States. In the CRL, the FDA explained their reasons for non-approval and provided recommendations for how to address the outstanding issues, primarily relating to the provision of additional clinical and statistical data and analyses pertaining to the primary endpoint of the completed pivotal Phase III study. As previously noted, these recommendations were covered by medac’s existing development plan for treosulfan, which medac is contractually responsible to execute and fund. The Company believes that the CRL provides a path to review and approval that does not require additional clinical studies, provided it can satisfy the FDA’s data and post marketing requirements.
Ken d’Entremont, CEO, commented, “We have been actively working with medac to prepare for its anticipated Type A Meeting and are pleased that it has been granted this meeting in line with our previously anticipated timeline. We remain positive on the outlook for treosulfan in the United States and look forward to continuing discussions with the FDA in order to meet the requirements for approval. We continue to believe that treosulfan has enormous potential in the United States, where the current market leading product, busulfan, reached US$126M in sales prior to genericization. In the meantime, we continue to ramp up sales in Canada, where we commercially launched in September of this year.”
Treosulfan was approved by Health Canada in June 2021, under the brand name Trecondyv®, and was granted marketing authorization in combination with fludarabine with the European Commission in June 2019.
https://www.globenewswire.com/news-release/2021/11/01/2324527/0/en/Medexus-Pharmaceuticals-Announces-Type-A-Meeting-with-FDA-Granted-for-Treosulfan.html