Roche’s MabThera/Rituxan has secured the FDA approval in June 2018 and the European Commission approval in March 2019

company-information-740

Image: Roche Tower in the city of Basel, northwest Switzerland. Photo: Courtesy of F. Hoffmann-La Roche Ltd.

Roche has unveiled positive results from the Phase III PEMPHIX study of MabThera/Rituxan (rituximab) compared to mycophenolate mofetil (MMF) in adults with moderate to severe pemphigus vulgaris (PV).

The pharmaceuticals firm said that the PEMPHIX study evaluating the efficacy and safety of MabThera/Rituxan (rituximab) has reached the primary endpoint at Week 52, indicating that the MabThera/Rituxan is superior to MMF.

Roche global product development head chief medical officer Levi Garraway said: “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.

“The PEMPHIX study showed that 40 percent 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.”

Phase III PEMPHIX study evaluated MabThera/Rituxan (rituximab) in treating PV

PV is a rare and potentially life-threatening disease condition that causes painful burning of the skin and mucous membranes, and MMF is an unapproved treatment commonly recommended for PV.

Roche’s MabThera/Rituxan has secured the FDA approval in June 2018 and the European Commission approval in March 2019 to become the first biologic therapy for PV.

The company said that the regulatory approvals were awarded based on the clinical data from Ritux 3 clinical trial, and its PEMPHIX study is aimed at providing additional clinical evidence of the effectiveness of MabThera/Rituxan for PV.

The Phase III PEMPHIX study has reached primary endpoint with 40.3% of patients achieving sustained complete remission (CR) without the use of steroids for 16 consecutive weeks or more, compared to 9.5% in the MMF arm.

The secondary endpoints including lower cumulative oral corticosteroid dose, fewer flares, a greater chance of sustained CR, greater improvement in Dermatology Life Quality Index (DLQI) at week 52, all were statistically in favour of MabThera/Rituxan, compared to the MMF arm.

The adverse events in the study were generally consistent compared to the previous MabThera/Rituxan clinical studies in PV and other approved autoimmune indications.