Multiple Sclerosis: Cenrifki (tolebrutinib) on Track for Approval in Europe
The Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion recommending the approval of Cenrifki (tolebrutinib) for the treatment of secondary progressive multiple sclerosis without relapses. A final decision by the European Commission is expected in the coming months.
Indications and Therapeutic Need
Cenrifki is recommended for the treatment of secondary progressive multiple sclerosis (SPMS) without relapses over the past two years. SPMS is a debilitating stage where patients experience a continuous accumulation of disability, including fatigue, cognitive disorders, mobility difficulties, and loss of autonomy, often in the absence of therapeutic options. Managing the progression of disability remains one of the most significant unmet needs in this indication.
Clinical Data and Safety Profile
The positive opinion of the CHMP is based on data from the phase 3 HERCULES study in SPMS without relapses, as well as two phase 3 studies in relapsing multiple sclerosis (GEMINI 1 and GEMINI 2), presented at scientific conferences and published in The New England Journal of Medicine. Cenrifki is an oral, brain-penetrating inhibitor of Bruton's tyrosine kinase, specifically designed to target pervasive neuroinflammation, a key factor in the progression of disability. The safety profile has been consistent across the clinical program. The most common adverse events were COVID-19 and upper respiratory tract infections. Significant elevations in liver enzymes were also observed, and drug-related liver injury is an identified safety risk of tolebrutinib, requiring strict adherence to liver monitoring requirements.
