Roche announced on Friday that the European Commission has approved 'MabThera' (rituximab) for the treatment of adults with moderate-to-severe pemphigus vulgaris (PV).
The Swiss pharmaceuticals giant described PV as a rare condition, characterised by progressive painful blistering of the skin or mucous membranes, with extensive blistering possibly leading to serious, life-threatening fluid loss, infection or death.
It said MabThera was the first biologic therapy approved by the EC for PV, and the first major advancement in the treatment of the disease in more than six decades.
Following approval by the US Food and Drug Administration (FDA) in June last year, and the fresh decision in Europe, MabThera was now approved to treat four autoimmune diseases in the US and Europe.
“We're pleased to bring the first biologic medicine to the more than 50,000 people in Europe suffering from pemphigus vulgaris,” said Roche's chief medical officer and head of global product development Sandra Horning.
“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.”
Roche said the European approval was based on data from the phase 3 'Ritux 3' trial, which was a Roche-supported randomised controlled study conducted in France.
It 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.
The primary endpoint of the study was complete remission at month 24 without the use of CS for two or more months.
Roche said the study demonstrated that 89.5% of people 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, compared to 27.8% of people with PV receiving CS alone, which was the current standard of care.
The Roche-sponsored phase 3 multicentre, randomised, double-blind PEMPHIX study, evaluating the efficacy and safety of MabThera compared with mycophenolate mofetil (MMF) – an immunosuppressant – in patients with moderate to severe PV, was ongoing.
The company also noted that recently, the International Bullous Disease Group published new recommendations on the diagnosis and management of pemphigus in the Journal of the American Academy of Dermatology, and recommended the use of an anti-CD20 monoclonal antibody – such as MabThera combined with a tapering regimen of oral CS – as a first-line therapy option for moderate to severe pemphigus.