Roche secures US paediatric approval for Rituxan in two rare forms of vasculitis
pharmafile | September 30, 2019 | News story | Sales and Marketing | MabThera, Rituxan, Roche, pharma, vasculitis
Roche has revealed that Rituxan (rituximab), also known as MabThera, has been awarded US approval from the FDA in combination with glucocorticoids for the treatment of granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MA) in children over the age of two years old.
The two conditions are forms of ANCA-associated vasculitis, broadly affecting the small blood vessels of the kidneys, lungs, and sinuses, among other areas. The approval marks the first for the drug in a paediatric indication.
The ruling was based on Global Phase 2a data in 25 participants aged between six and 17; at baseline, six patients had MPA while 19 had MPA. Patients received four weekly infusions of Rituxan ever four weeks in combination with oral glucocorticoids, with efficacy of the therapy measured using the Paediatric Vasculitis Activity Score (PVAS). On this basis, it was found that 56% of patients achieved PVAS remission by month 6, 92% by month 12, and 100% of patients achieved remission by month 18.
“Rituxan is now approved as the first and only medicine for paediatric patients living with GPA and MPA, two potentially life-threatening blood vessel disorders which are rare in children,” said Dr 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 paediatric patients with rare diseases where there is a serious unmet need.”
Rituxan is already approved for the treatment of these two conditions in adult populations, having been granted Priority Review from the FDA in this indication back in 2011, and was the first and only therapy approved for it by the US regulator.
Matt Fellows
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