Posted by Michael Wonder on 20 Oct 2018
FDA approves label update for Genentech’s Rituxan (rituximab) in two rare forms of vasculitis
19 October 2018 - Rituxan label updated to include information for follow up treatment in adult patients with granulomatosis with polyangiitis and microscopic polyangiitis who have achieved disease control with induction treatment.
Genentech announced today that the U.S. 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.
