Trecondi

treosulfan

Opinion

On 13 December 2018, 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, intended for the conditioning treatment prior to allogeneic haematopoietic stem cell transplantation (alloHSCT). Trecondi was designated as an orphan medicinal product on 23 February 2004. The applicant for this medicinal product is medac Gesellschaft fur klinische Spezialpraparate mbH.

Trecondi will be available as a 50 mg/ml powder for solution for 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.”

It is proposed that Trecondi be prescribed by physicians experienced in conditioning treatment followed by alloHSCT.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.


* The word “injection” has been deleted.

Key facts

Name
Trecondi
Agency product number
EMEA/H/C/004751
International non-proprietary name (INN) or common name
  • treosulfan
Active substance
  • Treosulfan
Therapeutic area
Hematopoietic Stem Cell Transplantation
Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Date opinion adopted
13/12/2018
Company name
medac Gesellschaft für klinische Spezialpräparate mbH
Status
Positive
Application type
Initial authorisation

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