Medexus Pharmaceuticals and medac GmbH announced this week that they have received a Complete Response Letter from the FDA.
The agency rejected the New Drug Application for treosulfan, a medication developed to be used in combination with fludarabine in preparation for allogeneic hematopoietic stem cell transplantation to decrease tumor burden. The news dumbfounded the companies given that treosulfan has already been approved for use in Canada and the EU.
“Given the recent Health Canada approval, European Medicines Agency approval in 2019, as well as supporting data from more than 100 publications, we were all surprised by the FDA’s response,” Ken d’Entremont, CEO of Canada-based Medexus, said in a statement.
In its CRL, the agency asked the companies for additional statistical data and analysis related to the primary and secondary endpoints in the drug’s pivotal phase 3 trial. The companies said they had hoped to launch treosulfan later this year, but are now working with the FDA to determine the next steps.
