MabThera gets EC approval for a rare autoimmune disease

The FDA approved Roche’s MabThera (rituximab) in June 2018, and now the European Commission has also approved the drug for the treatment of adults with moderate to severe pemphigus vulgaris, based on data from the phase III Ritux 3 trial.
The phase III trial evaluated MabThera plus a tapering regimen of oral corticosteroids (CS) versus a standard dose of CS alone, as a first-line treatment in patients with newly diagnosed moderate to severe pemphigus. 89.5% of those with PV treated with MabThera, in combination with short-term oral CS treatment, achieved complete remission without the use of CS for two or more months, versus 27.8% of those with PV receiving CS alone. The primary endpoint of the study was complete remission at month 24 without the use of CS for two or more months.
Roche’s Chief Medical Officer and Head of Global Product Development, Sandra Horning, said: “We’re pleased to bring the first biologic medicine to the more than 50,000 people in Europe suffering from pemphigus vulgaris. This MabThera approval provides a much needed new treatment that has been shown to provide higher remission rates than corticosteroids alone, which can cause debilitating side effects.”