FDA approves new Rituxan indication

Roche has received the Food and Drug Administration’s clearance for Rituxan (rituximab), in combination with glucocorticoids, for the treatment of granulomatosis with polyangiitis, or GPA and microscopic polyangiitis, or MPA in pediatric patients 2 years of age and older. GPA and MPA are rare, potentially life-threatening diseases affecting small and medium sized blood vessels.

“Rituxan is now approved as the first and only medicine for pediatric patients living with GPA and MPA, two potentially life-threatening blood vessel disorders which are rare in children,” said Sandra Horning,  Roche’s chief medical officer and head of global product development. “Today’s approval is a result of our ongoing commitment to working with the FDA to develop medicines for pediatric patients with rare diseases where there is a serious unmet need.”

The FDA previously granted priority review to Rituxan for the treatment of GPA and MPA in pediatric patients. In 2011, Rituxan became the first and only therapy approved by the FDA for the treatment of adults with these two rare forms of vasculitis.

Rituxan is currently indicated for the treatment of four autoimmune conditions and since 2006 more than 900,000 people have been treated with MabThera/Rituxan for autoimmune conditions worldwide. MabThera/Rituxan is not indicated in children less than 2 years of age with GPA or MPA, or in children with conditions outside of GPA and MPA.