Roche has dived into the data behind its filing for FDA approval of fenebrutinib in multiple sclerosis (MS), unpacking the BTK inhibitor’s effect on chronic active lesions, disease control and brain volume.
The Swiss drugmaker has reported a series of phase 3 wins for the drug candidate over the past year. Armed with the data, Roche recently filed for FDA approval of fenebrutinib in relapsing and primary progressive MS (RMS/PPMS). With the FDA accepting the filing, the company is on track to launch the product next year.
Roche shared different slices of the data at the MSToronto2026 conference. The company linked fenebrutinib to an up to 30% reduction in the volume of slowly expanding lesions. Roche also reported a 62% reduction in the accumulation of paramagnetic rim lesions in RMS.
Hailing the result as the first prospective demonstration of a therapeutic effect on chronic active lesions in a phase 3 trial, Roche said the data show that fenebrutinib directly targets chronic inflammation in the brain. Chronic inflammation is a primary driver of disability progression in MS.
Physicians have identified disability progression as a key battleground for the coming wave of MS drugs. In a note to investors last month, Guggenheim Securities analysts called confirmed disability progression (CDP) “a potential swing factor” for the MS market.
Three experts told the analysts that evidence of a medicine’s effect on CDP could justify moving a BTK inhibitor ahead of an anti-CD20 drug in the treatment pathway.
Against this backdrop, Roche reported a numerical reduction in the risk of 12-week composite CDP in its two phase 3 RMS trials. Pooling the RMS data, Roche reported a 12-week composite CDP reduction of 16% at the Toronto meeting.
The company shared the CDP data as part of an oral presentation that linked fenebrutinib to a 23% reduction in annual total brain volume loss. Roche argued the findings demonstrate the drug candidate’s potential to control relapses, slow brain tissue loss and preserve function.
Roche has argued the data can support blockbuster sales and is more bullish on the product than analysts. At an event last month, Roche Pharmaceuticals CEO Teresa Graham said the analyst consensus for peak sales is about 1 billion Swiss francs ($1.2 billion). Graham predicted fenebrutinib could “get that in PPMS alone.”
Where Big Pharma is placing its bets is one of the hot topics being discussed at Fierce Biotech's high-impact event in London next month. Find out more information and register by clicking on the banner below:
