CHMP recommends approval of Trecondi in haematopoietic stem cell transplantation.- Medac GmbH.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Trecondi (treosulfan), from Medac GmbH, intended for the conditioning treatment prior to allogeneic haematopoietic stem cell transplantation (alloHSCT). Trecondi will be available as a 50 mg/ml powder for solution for injection/infusion.
The active substance of Trecondi is treosulfan, a prodrug of an alkylating agent with cytotoxic activity against haematopoietic precursor cells (ATC code: L01AB02). The benefit with Trecondi is the increase of the rate of event-free survival after 2 years. The most common side effects are infections (bacterial, viral, fungal), stomatitis/mucositis, diarrhoea, nausea, vomiting and abdominal pain.
The full 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 older than one month with malignant diseases.�
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