FDA green lights new pediatric approval for Rituxan

The US Food and Drug Administration has approved Rituxan (rituximab), in combination with glucocorticoids, for the treatment of granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in pediatric patients two years of age and older.

This represents the first approved treatment for children with these rare, potentially life-threatening, vasculitis diseases.

Rituxan, developed by Swiss pharma giant Roche’s (ROG: SIX) subsidiary Genentech, was previously granted Priority Review by the FDA for the treatment of GPA and MPA in pediatric patients. Rituxan/MabThera generated sales of some $6.75 billion in 2018, but is now facing competition from biosimilars.

“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 Dr Sandra Horning, chief medical officer and head of global product development, adding: “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.”

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