Rituximab gets EC nod for pemphigusMay 8, 2019
Rituximab (MabThera) received approval from the EC for the treatment of adults with moderate to severe pemphigus vulgaris (PV), a rare condition characterised by progressive painful blistering of the skin and mucous membranes.
Rituximab is the first biologic therapy approved by the EC for PV and the first major advancement in the treatment of the disease in more than 60 years, Roche said.
The European approval is based on data from the phase III Ritux 3 trial, a randomised controlled study conducted in France, which evaluated rituximab plus a tapering regimen of oral corticosteroids (CS) compared to a standard dose of CS alone, as a first-line treatment in patients with newly diagnosed moderate to severe pemphigus.
The primary endpoint of the study was complete remission at month 24 without the use of CS for two or more months. The study demonstrated that 89.5% of people with PV treated with rituximab, in combination with short-term oral CS treatment, achieved complete remission without the use of CS for two or more months, compared to 27.8% of people with PV receiving CS alone, the current standard of care.
The phase III multicentre, randomised, double-blind PEMPHIX study, evaluating the efficacy and safety of rituximab compared with mycophenolate mofetil (MMF), an immunosuppressant, in patients with moderate to severe PV, is ongoing.
PV is the most common type of a group of autoimmune disorders collectively called pemphigus.