Medac Resubmits NDA for Treosulfan Following Complete Response Letter

Medac has resubmitted its New Drug Application (NDA) for treosulfan in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation.

The FDA rejected the initial NDA in August 2021 in a Complete Response Letter that called for more supporting data and analysis from the company’s phase 3 study. Medac previously resubmitted the NDA in April but the agency requested more information.

The company is hoping for approval within six months from the accepted resubmission date. The agency has not yet said whether the latest NDA is complete.

Teosulfan received EU marketing authorization in 2019. It is sold under the brand name Trecondi, for infusion to people before they have a bone marrow transplant from a donor.