Roche announced the Phase 3 PEMPHIX trial indicating the superiority of Rituxan (rituximab) in the treatment of pemphigus vulgaris. The US FDA has approved Rituxan for the treatment of pemphigus vulgaris in June 2018. It is the only biologic therapy approved for the treatment of pemphigus vulgaris.
Genentech has compared the Rituxan with mycophenolate mofetil (MMF) in adults with moderate to severe pemphigus vulgaris.
Percentage of patients achieved sustained complete remission after corticosteroid therapy was the primary endpoint. Sustained complete remission was defined as no disease activity as measured by Pemphigus Disease Area Index without steroids for 16 weeks. The primary endpoint was measured after one year of treatment. Secondary endpoints include cumulative corticosteroid dose, number of flares time to sustained remission, and time to disease flare. The results will be presented in the medical congress.
Earlier, the product has been approved based on the Ritux clinical trial.
Pemphigus vulgaris is a rare, life-threatening condition