In the pivotal FENtrepid trial, Roche’s BTK inhibitor fenebrutinib demonstrated a meaningful reduction in disability progression in Primary Progressive Multiple Sclerosis (PPMS), performing at least on par with OCREVUS—the current standard and only approved treatment for PPMS.
BTK Inhibitor | 15/11/2025 | By Dineshwori
FDA Approves Novartis's Rhapsido as First Oral BTK Inhibitor for Chronic Spontaneous Urticaria
The US Food and Drug Administration (FDA) has approved Novartis’ Rhapsido (remibrutinib) as an oral treatment for adult patients with chronic spontaneous urticaria (CSU) who continue to experience symptoms despite H1 antihistamine therapy.
BTK Inhibitor | 03/10/2025 | By Dineshwori | 199
US FDA Clears Sanofi's Wayrilz, First BTK Inhibitor for ITP
The US FDA approval was based on the pivotal LUNA 3 phase-III study, in which Sanofi’s Wayrilz met the primary and secondary endpoints, showing a positive impact on sustained platelet counts and other ITP symptoms.
BTK Inhibitor | 30/08/2025 | By Dineshwori | 152
Sanofi Reveals Positive Results of Tolebrutinib in HERCULES Phase 3 Study
In the HERCULES study, nrSPMS was defined at baseline as having an SPMS diagnosis with an expanded disability status scale (EDSS) score between 3.0 and 6.5, no clinical relapses for the previous 24 months and documented evidence of disability accumulation in the previous 12 months.
BTK Inhibitor | 03/09/2024 | By Aishwarya | 475
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