Roche's fenebrutinib significantly reduced brain lesions in MS patients

17 May 2023

Positive results from the Phase II FENopta study evaluating investigational oral fenebrutinib in adults with relapsing forms of multiple sclerosis (RMS) have been released by Swiss pharma giant Roche (ROG: SIX).

Fenebrutinib is a highly selective oral Bruton’s tyrosine kinase (BTK) inhibitor. The study met its primary and secondary endpoints, showing oral fenebrutinib significantly reduced magnetic resonance imaging (MRI) markers of MS disease activity in the brain compared to placebo. Additionally, pre-clinical data have shown fenebrutinib to be potent and highly selective, and it is the only reversible inhibitor currently in Phase III trials for MS.

Assuming that fenebrutinib gains regulatory approval, which analysts have said is also slated for launch in 2027, it would enter an MS market expected to be worth $30 billion 2030, according to research from GlobalData. It would also join Roche’s MS drug Ocrevus (ocrelizumab), with projected revenues of $6.3 billion.

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