Breaking news: tolebrutinib is licensed by the EU for treating non-relapsing SPMS
Tolebrutinib is the first licensed treatment to directly impact smouldering MS
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Tolebrutinib (Cenrifki), for the treatment of multiple sclerosis.
Tolebrutinib (Cenrifki) will be available as 60 mg film-coated tablets. As you know, Tolebrutinib is a second-generation inhibitor of Bruton’s tyrosine kinase (BTKi).
The benefits of Tolebrutinib (Cenrifki) include a 31% reduction in the risk of 6-month confirmed disability progression and a 38% reduction in the adjusted mean number of new and/or enlarging T2-hyperintense lesions per year compared with patients receiving placebo.
The most common side effects of Tolebrutinib (Cenrifki) are infections, petechiae (haemorrhages), an increased tendency to bruise, heavy menstrual bleeding, abdominal pain, contusion, and elevated liver enzyme levels. The most worrisome side effect is the drug-induced liver injury.
The full indication is:
Tolebrutinib (Cenrifki) is indicated for the treatment of adult patients with secondary progressive multiple sclerosis (SPMS) without relapses in the last 2 years (see section 5.1).
Cenrifki should be prescribed by physicians experienced in treating multiple sclerosis.
Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorisation has been granted by the European Commission.
Let’s hope the MHRA does likewise, in parallel with NICE. People with smouldering non-relapsing SPMS deserve access to this treatment sooner rather than later.
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Please note that the opinions expressed here are those of Professor Giovannoni and do not necessarily reflect the positions of Queen Mary University of London or Barts Health NHS Trust. The advice is intended as general and should not be interpreted as personal clinical advice. If you have any problems, please tell your healthcare professional, who can help you.
That’s fantastic news, I’ll be lobbying hard for MHRA and NICE approval.
How amazing! And brilliant that you could break this news so quickly - thank you!