FDA approves update to Rituxan label to include information on treatment of rare forms of vasculitis

Genentech, a member of the Roche Group, announced today that the U.S. Food and Drug Administration (FDA) has approved an update to the Rituxan^® (rituximab) label to include information on follow up treatment of adult patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) who have achieved disease control with induction treatment. The label update was based on data from a Roche-supported study by the French Vasculitis Study Group showing that treatment with the rituximab regimen resulted in fewer major relapses by month 28 compared to treatment with azathioprine. The observed safety profile was consistent with that previously observed in this patient population. Rituxan, in combination with glucocorticoids (GCC), was approved by the FDA in 2011 for adult patients with GPA and MPA.

"Options for continued treatment in GPA and MPA, chronic autoimmune diseases in which patients experience periods of flares, are currently limited," said Sandra Horning, M.D., chief medical officer and head of Global Product Development. "As part of our commitment to support people living with rare diseases, we are pleased to provide updated prescribing information for Rituxan to help physicians make more informed decisions about therapeutic options for patients who have achieved disease control with induction treatment."

GPA and MPA are two types of ANCA-associated vasculitis (AAV), a form of vasculitis, or inflammation of the blood vessels, that largely affects the small blood vessels of the kidneys, lungs and a variety of other organs. Rituxan, in combination with glucocorticoids (GCC), was approved by the FDA in 2011 for adult patients with GPA and MPA, with the precaution that limited data were available on the safety and efficacy of subsequent courses of Rituxan in patients with GPA and MPA, and that the safety and efficacy of retreatment with Rituxan had not been established. As part of this label update, the precaution has been removed from the Rituxan prescribing information.

The U.S. label update is based on data from the MAINRITSAN trial, a Roche-supported, randomized, controlled clinical trial, conducted by the French Vasculitis Study Group, that used Roche-manufactured, European Union (EU)-approved rituximab as the clinical trial material. The study evaluated the efficacy and safety of the rituximab regimen compared to azathioprine as follow up treatment in 115 patients (86 with GPA, 24 with MPA, and 5 with renal-limited AAV), who had achieved disease control after induction of remission with GCC and cyclophosphamide. The primary endpoint was the occurrence of major relapse^† through month 28. By month 28, major relapse occurred in 3 patients (5 percent) on the rituximab regimen* and 17 patients (29 percent) in the azathioprine group.