Sage Represents Trecondi® from Medac GmbH: Novel Product for Conditioning in AML and MDS Patients:O
Sage Group is working with medac GmbH who have developed Trecondi®, (Treosulfan), as a superior drug in conjunction with fludarabine prior to allogeneic hematopoetic stem cell transplantation (alloHSCT) in patients suffering from AML or MDS.
medac completed a European clinical study of 570 patients (NCT 00822393). This randomized Phase III trial was designed as a non-inferiority study of a Trecondi® conditioning compared to a busulfan conditioning in adult patients with AML or MDS who were ineligible for standard myeloablative conditioning regimens.
This study showed Trecondi® to be superior with respect to event-free-survival compared to busulfan in the selected patient population.
medac has received guidance from the FDA that as a 505(b)(1) NDA, no additional clinical study will be requested for US Marketing Authorization.
medac has received European Marketing Authorization in 2019 and initiated distribution of Trecondi®
The EMA label indication is: Treosulfan in combination with fludarabine is indicated as part of conditioning treatment prior to allogeneic haematopoietic stem cell transplantation (alloHSCT) in adult patients with malignant and non- malignant diseases and in paediatric patients with malignant diseases older than one month.”
medac seeks a partner to commercialize Trecondi® in the USA in anticipation of FDA approval in 2021 and to initiate an Expanded Access Programme.
For more information, please contact either
Dr. Bill Mason