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The European Medicines Agency (EMA) announcements

October 20, 2022 | General

ESOT would like to share two recent transplant-related announcements made by the EMA.


EMA consultation: iBox Scoring System in kidney transplant patients

The EMA has published for public consultation a “draft qualification opinion for the iBox Scoring System as a secondary efficacy endpoint in clinical trials investigating novel immunosuppressive medicines in kidney transplant patients”.

The Committee for Medicinal Products for Human Use (CHMP) has qualified this scoring system to be used in clinical trials to support the evaluation of novel immunosuppressive therapy applications.

The EMA are receiving comments on this consultation until 17 November 2022.

Read the scoring system and provide comments here.


EMA communication: First therapy to treat transplant patients with post-transplant lymphoproliferative disease

The EMA have recommended a marketing authorisation in the EU for Ebvallo (tabelecleucel) for the treatment of patients who experience a significant complication following solid organ transplantation or bone marrow transplantation.

This is the first therapy to treat transplant patients with post-transplant lymphoproliferative disease, one of the most detrimental malignancies after transplantation caused by immunosuppression. Ebvallo aims to target eliminate all signs of cancer to assist in pro-longed survival and ultimately reduce transplant related mortality.

The European Commission will now adopt a decision on the EU-wide marketing authorisation of Ebvallo.

Read more information here.

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