Tag: Fenebrutinib

Regulatory Approval Clinical Data Healthcare & Pharmaceuticals News

Roche Fenebrutinib FDA Filing Accepted Under Priority Review for Relapsing and Primary Progressive Multiple Sclerosis.

Roche News
Roche News

The Roche fenebrutinib FDA filing has been accepted under priority review for relapsing and primary progressive multiple sclerosis. The application draws on the FENhance 1, FENhance 2 and FENtrepid Phase III studies.

Clinical Trials Healthcare & Pharmaceuticals News Oncology

Roche’s Fenebrutinib Shows “Unprecedented” Phase III Success in Both Relapsing and Progressive Multiple Sclerosis

Roche

Roche announced today that its investigational oral medication, fenebrutinib, has met primary endpoints in two separate, pivotal Phase III studies for both relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). The drug significantly reduced relapse rates in RMS and slowed disability progression in PPMS, positioning it as a potential first-in-class, high-efficacy oral treatment for the two most common forms of the disease.