Posted by Michael Wonder on 16 Mar 2019
European Commission approves Roche’s MabThera (rituximab) for a rare auto-immune disease
15 March 2019 - MabThera is now approved in Europe to treat four auto-immune diseases.
Roche today announced that the European Commission has approved MabThera (rituximab) for the treatment of adults with moderate to severe pemphigus vulgaris, a rare condition characterised by progressive painful blistering of the skin and/or mucous membranes.
The European approval is based on data from the phase III Ritux 3 trial, a Roche-supported randomised controlled study, conducted in France, which evaluated MabThera 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.
