Roche Holding AG said the European Commission approved MabThera for patients with pemphigus vulgaris, a rare condition affecting the skin and mucus membranes.
Pemphigus vulgaris is characterized by progressive painful blistering that can lead to life-threatening fluid loss, infection or death. The EU regulator approved MabThera, or rituximab, for patients with moderate to severe types of the disease.
The approval is based on data from a phase 3 study, called Ritux 3, which compared a combination of MabThera plus short-term corticosteroids to corticosteroids alone as an initial treatment for patients with newly diagnosed moderate to severe disease. In the study, 89.5% of those treated with the MabThera combination went into remission, compared with 27.8% of those who took steroids alone.
MabThera is a monoclonal antibody that targets the B-lymphocyte antigen CD20, which is mainly found on the surface of immune cells.
MabThera, also sold in the U.S. as Rituxan, was approved by the U.S. Food and Drug Administration in June 2018 for treating pemphigus vulgaris. The U.S. FDA first approved rituximab in 1997 to treat patients with a certain type of non-Hodgkin lymphoma.
Basel, Switzerland-based Roche is facing biosimilar competition for MabThera in the EU, primarily from Novartis AG's Rixathon.