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EAN 2026 | EU approval of tolebrutinib marks new era in progressive multiple sclerosis

Celia Oreja-Guevara, MD, PhD, University Hospital San Carlos, Madrid, Spain, comments on the recent approval of tolebrutinib in the EU for the treatment of multiple sclerosis (MS) for secondary progressive multiple sclerosis without relapses. Dr Oreja-Guevara highlights the impact of this approval, which is the first treatment targeting disease progression. This interview took place at the 12th Congress of the European Academy of Neurology (EAN) in Geneva, Switzerland.

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Transcript

Tolebrutinib was approved one week ago by the EMA and we are very happy because it’s the first BTK inhibitor, the first approval of a BTK inhibitor and this is the first treatment that will target the microglia. So this treatment is for secondary progressive MS without relapses in the last two years. So it means for these patients that they have this worsening of the disease without relapses, without inflammation...

Tolebrutinib was approved one week ago by the EMA and we are very happy because it’s the first BTK inhibitor, the first approval of a BTK inhibitor and this is the first treatment that will target the microglia. So this treatment is for secondary progressive MS without relapses in the last two years. So it means for these patients that they have this worsening of the disease without relapses, without inflammation. So it means it’s for these patients that they have walking difficulties, patients that have more fatigue, more cognitive alterations, and they see that they are worsening without any reason. So we are very happy that we will have now the first treatment for the progression of the disease. That is really a new milestone. So, and I think that we will try to use this treatment after the summer. So that I think that the first country will be Germany, but later we will have more countries in the European Union, so that I think that will be very good news for the patients, because we will have the first treatment to try to improve the progress, to try to stop or to improve the progression of the disease.

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