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Roche's Phase 3 Pemphix trial smashes primary endpoint for pemphigus vulgaris

Published on 14/10/19 at 10:05am

Roche has revealed new Phase 3 data demonstrating that its MabThera/Rituxan (rituximab) therapy Pemphix met its primary endpoint in the treatment of moderate to severe pemphigus vulgaris (PV) in adult patients.

The findings revealed that 40.3% of patients on Roche’s drug achieved complete remission which was sustained for at least 16 weeks without the use of steroids, compared to just 9.5% of those on  mycophenolate mofetil (MMF), achieving the study’s primary endpoint.

The results also illustrated that Pemphix also performed better with regards to the trial’s secondary endpoints, recording a lower cumulative oral corticosteroid dose, a greater likelihood of sustained complete remission, and fewer flares with just six versus 44 with MMF.

Roche’s study is ongoing with a 48-week safety follow-up.

“The approval of MabThera/Rituxan for the treatment of pemphigus vulgaris was the first major advancement in the treatment of this rare, serious disease in more than 60 years,” commented Dr Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development. “The PEMPHIX study showed that 40% of people in the study could achieve complete remission from painful blistering without the need for corticosteroids for 16 weeks or more and that Mabthera/Rituxan may be a superior treatment option to mycophenolate mofetil.”

Matt Fellows

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