- Medexus Pharmaceuticals (TSX:MDP) has revealed that the U.S. Food and Drug Administration has extended the review period for the company’s new drug application for treosulfan by three months
- The new target action date has now been set for Jan. 30, 2025
- The company is seeking a new drug application of treosulfan in combination with fludarabine as a preparative procedure in adult and child patients with different blood cancers
- Shares of Medexus Pharmaceuticals are down 17.58 per cent to C$2.25 as of 12:19 pm ET
Medexus Pharmaceuticals (TSX:MDP) has revealed that the U.S. Food and Drug Administration (FDA) has extended the review period for the company’s new drug application for treosulfan by three months.
The company stated in a news release that Medac, the licensor of Medexus’ commercial rights for treosulfan, stated that the new target action date has now been set for Jan. 30, 2025.
“We recognize that this development further extends the regulatory review process timeline,” Ken d’Entremont, CEO of Medexus Pharmaceuticals, said in a statement. “Nevertheless, we are encouraged to see that the FDA remains actively engaged with Medac, and we continue to prepare for an approval of treosulfan in the United States and a commercial launch in the first half of calendar year 2025.”
The FDA explained that it needs more time to properly review supplemental analyses of previously submitted data provided by Medac in response to the FDA’s routine information requests, which can take up to three more months for review. Additional submission of new clinical data has not been requested by the regulatory agency.
Through the NDA application, Medexus is seeking approval of treosulfan in combination with fludarabine in adult and child patients with acute myeloid leukemia and myelodysplastic syndromes, which are rare blood cancers, as a precautionary measure for allogenic hematopoietic stem cell transplantation.
Medexus Pharmaceuticals is a specialty pharmaceutical company with a portfolio of rare disease treatment solutions. The company is focused on the therapeutic areas of oncology, hematology, rheumatology, auto-immune diseases, allergy and dermatology.
Shares of Medexus Pharmaceuticals (TSX:MDP) are down 17.58 per cent to C$2.25 as of 12:19 pm ET.
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