MT Pharma withdraws its European marketing application for edaravone
We are disappointed that there remains only one approved treatment for MND in the UK as MT Pharma has withdrawn its marketing authorisation application for edaravone (Radicava).
You can read their official withdrawal letter here. The letter indicates that MT Pharma were not expecting a positive outcome from the European Medicines Agency (EMA). At the time of withdrawal, an EMA subcommittee – the Committee for Medicinal Products for Human Use (CHMP) had concerns, particularly that the MT Pharma study involved only a small number of patients and there was not enough evidence of improvements in measures, such as those related to survival, breathing and muscle strength.
We trust that MT Pharma will work closely with the European Clinical MND Research Community in seeking further evidence in support of a future submission to the EMA.
Meantime, we are seeing a continued growth in new and exciting research, with more drug trials in development than ever before. You can read more on the background to edaravone in our research blog and about other drug trials on our website.