Fenebrutinib

Roche reports 6% Group sales growth at constant exchange rates, driven by high demand for medicines and diagnostics. Pharmaceuticals Division sales rose 7%, with strong growth in base business, led by Vabysmo, Phesgo, and Ocrevus. Diagnostics Division sales increased 5%, with base business growing 8%. Key developments include US and EU approvals for new treatments, positive phase III data, and acquisitions to strengthen pipelines. Outlook for 2024 is confirmed.

Genentech's fenebrutinib, a non-covalent BTK inhibitor in Ph. III, showed significant CNS exposure and reduced new brain lesions in Ph. II for relapsing MS. It is the only reversible BTK inhibitor in Ph. III for MS, potentially differentiating on safety from covalent inhibitors.

Fenebrutinib, Roche’s BTK inhibitor, effectively suppressed disease activity and halted disability progression in RMS patients for up to 48 weeks, with 96% experiencing no relapses and 99% free of T1-Gd+ lesions. The drug's safety profile remained consistent, with mild AEs reported.

Sanofi's phase 3 HERCULES study of tolebrutinib met primary endpoint of reducing disability in non-relapsing secondary progressive multiple sclerosis (nrSPMS). Roche's fenebrutinib showed significant relapse suppression in relapsing MS without disability change. FDA accepted Axsome Therapeutics' resubmitted NDA for AXS-07 for acute migraine treatment.

Roche's Phase II study of BTK inhibitor fenebrutinib shows 96% of RMS patients relapse-free at one year, with no disability change and 99% free of T1-Gd+ lesions. The safety profile remains consistent, with ongoing Phase III trials expected to validate these results.