FDA Reviews Treosulfan NDA Resubmission

On June 6, 2024, Medexus Pharmaceuticals received confirmation from medac, the licensor of its commercialization rights, that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug Application (NDA) for treosulfan. This application, resubmitted in April 2024, aims to secure FDA approval for treosulfan in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in both adult and pediatric patients. The FDA is expected to complete its review and make a decision by October 30, 2024. The resubmission includes additional information previously requested by the FDA regarding the pivotal phase 3 clinical trial of treosulfan conducted by medac.

Ken d'Entremont, CEO of Medexus, expressed optimism about this development. He highlighted the positive engagement with the FDA and the potential of treosulfan to become a leading treatment option in the U.S., similar to its status in Europe and Canada. d'Entremont emphasized that approval in the U.S. would significantly enhance Medexus's revenue streams.

The company had previously launched treosulfan in Canada under the brand name Trecondyv® in September 2021. The product's success in the Canadian market has bolstered Medexus's confidence in its potential impact in the U.S. market, contingent on FDA approval.

In September 2023, Medexus amended its February 2021 exclusive license agreement with medac related to the commercialization of treosulfan in the U.S. This amendment specifies a negotiation period to agree on further adjustments to the value of unpaid regulatory and sales-based milestone payments. Medexus is not obligated to make any milestone payments before any such adjustments are finalized.

Medexus Pharmaceuticals is a prominent specialty pharmaceutical company with a strong North American commercial presence. The company focuses on providing innovative treatment solutions for rare diseases, particularly in the fields of oncology, hematology, rheumatology, auto-immune diseases, allergy, and dermatology. 

This recent development marks a significant step for Medexus as it continues to expand its portfolio and enhance its market presence in North America. The outcome of the FDA review will be critical not just for the company’s financial prospects but also for patients who stand to benefit from a new therapeutic option in the U.S.

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