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
Sage Healthcare Ltd.
The Old Black Barns
Lord’s Lane, Ousden CB8 8TX
Phone: +44 1638 500775
Mob: +44 7785 950134
The Sage Group Inc.
1802 Route 31 North, #381
Clinton, NJ 08809
Phone: +1 908-231-9644
Mob: +1 908 2306170