Roche’s investigational oral therapy  fenebrutinib could become a new treatment option across relapsing and primary progressive multiple sclerosis if approved.

 

As per Roche, the US Food and Drug Administration has already accepted its New Drug Application for fenebrutinib, an investigational non-covalent Bruton’s tyrosine kinase (BTK) inhibitor, and granted the application priority review.

 

The filing seeks approval of fenebrutinib for adults with relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). It is backed by data from three Phase III trials — FENhance 1, FENhance 2 and FENtrepid — spanning both relapsing and progressive forms of the disease.

 

"People living with multiple sclerosis need treatments that go beyond controlling relapses to help preserve function and independence as the disease progresses," said Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development. 

 

"Three Phase III studies have demonstrated the potential for fenebrutinib to address both relapsing and progressive disease, thereby bringing us closer to an oral treatment that could make a meaningful difference across the MS spectrum."

 

Roche said the application marks a potential step toward an oral high-efficacy therapy capable of addressing both relapsing and primary progressive MS.

 

“Ocrevus transformed how we treat MS, helping more than 525,000 people live a life less defined by their disease. Yet, over a third of all people with MS still receive lower-efficacy treatment,” said Teresa Graham, Roche’s Chief Executive Officer, Pharma. 

 

“If approved, fenebrutinib could open a new chapter as the first high-efficacy oral therapy for both relapsing and primary progressive MS, helping to control disease activity while giving people more flexibility and choice.”

 

Roche said the FENhance 1 and FENhance 2 trials demonstrated significant reductions in relapses and both active and chronic brain lesions compared with teriflunomide, a standard treatment for RMS.

 

Fenebrutinib cut the annualised relapse rate by 51.1% in FENhance 1 and 58.5% in FENhance 2 over 96 weeks, compared with teriflunomide. Roche said the results correspond to approximately one relapse every 17 years — the lowest relapse rate reported in Phase III MS studies.

 

Measures of disability progression, including 12-week composite confirmed disability progression, also showed positive trends favouring fenebrutinib.

 

The FENtrepid trial focused on PPMS, where treatment options remain limited. Roche said fenebrutinib met its primary endpoint by demonstrating non-inferiority to Ocrevus (ocrelizumab), the current standard of care and only approved medicine for PPMS.

 

Fenebrutinib numerically reduced the risk of disability progression by 12% compared with Ocrevus, based on time to onset of 12-week composite confirmed disability progression. The hazard ratio was 0.88, with a 95% confidence interval of 0.75 to 1.03. Roche said the treatment curves began separating as early as 24 weeks.

 

The company also reported a consistent treatment effect across patient subgroups, including people without active inflammation.