The European Commission (EC) has approved Cenrifki for adults with secondary progressive multiple sclerosis (MS) who had no relapses in the previous two years.
The decision follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use.
Sanofi said Cenrifki, also known as tolebrutinib, is the first disease-targeting therapy approved in the EU that is designed to address the underlying process of disability accumulation in this group.
Secondary progressive multiple sclerosis, or SPMS, is a stage of MS in which disability continues to worsen, sometimes without further relapses.
The approval was based on the phase 3 HERCULES trial in people with non-relapsing SPMS, supported by data from the phase 3 GEMINI 1 and GEMINI 2 trials in relapsing MS.
HERCULES found that the medicine significantly delayed the onset of disability progression.
The most common adverse events across the clinical programme were COVID-19 and upper respiratory tract infections.
Significant increases in liver enzymes were also recorded. Drug-induced liver injury, known as DILI, is an identified risk, requiring strict liver monitoring and prompt management of raised enzyme levels.
Sanofi plans to make the treatment commercially available in Germany during 2026, supported by a risk management programme and patient support programme.
SPMS can cause fatigue, cognitive impairment, mobility difficulties and loss of independence as disability accumulates.
HERCULES participants had an Expanded Disability Status Scale score of between 3.0 and 6.5, had experienced no clinical relapses during the previous 24 months and had shown evidence of worsening disability during the previous year.
They were randomly assigned in a two-to-one ratio to receive either a daily oral dose of tolebrutinib or a matching placebo for up to about 48 months.
The main measure was disability progression confirmed over six months using the Expanded Disability Status Scale, which measures the level of disability caused by MS.
Progression was defined as an increase of at least 1.0 point for participants with a baseline score of 5.0 or lower, or at least 0.5 points for those with a score above 5.0.
Other measures included disability progression confirmed over three months, new or enlarging brain lesions detected by MRI, disability improvement, hand function, walking speed and the treatment’s safety and tolerability.
The GEMINI studies compared tolebrutinib with teriflunomide, an existing oral disease-modifying medicine for relapsing MS.
Participants were randomly assigned in equal numbers to receive either tolebrutinib and a placebo or 14mg of teriflunomide and a placebo each day.
The main measure was the annualised relapse rate over approximately 36 months. Other measures included confirmed disability worsening, MRI-detected brain lesions and safety and tolerability.
Cenrifki is an oral, brain-penetrant Bruton’s tyrosine kinase inhibitor designed to block an enzyme involved in immune activity.
It is intended to target smouldering neuroinflammation, persistent inflammation in the brain and spinal cord that is considered a key driver of disability progression in MS.
The medicine is taken once daily with a meal. Treatment must be started and supervised by a doctor experienced in managing multiple sclerosis.
Cenrifki is also approved in Australia to treat non-relapsing SPMS and slow disability accumulation in SPMS without relapse activity.
It is approved in the United Arab Emirates for SPMS without relapses during the previous two years.
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