GPA and MPA are two different types of ANCA-associated vasculitis (AAV) that primarily affects small blood vessels of the kidneys, lungs, sinuses, and other organs
Image: Rituxan has become the first and only therapy FDA approved treatment for both vasculitis. Photo: Courtesy of The U.S. Food and Drug Administration/Wikipedia.
Genentech, a biotechnology company of Roche Group, has secured the US Food and Drug Administration (FDA) approval for its Rituxan (rituximab), in combination with glucocorticoids.
FDA has approved Rituxan for the treatment of granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in pediatric patients aged two years and older.
Genentech global product development head and chief medical officer Sandra Horning said: “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.
“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.”
GPA and MPA affect kidneys, lungs, sinuses, and other organs
FDA has previously granted Priority Review to Rituxan for the treatment of GPA and MPA, which are rare, potentially deadly diseases affecting small and medium-sized blood vessels.
GPA and MPA are two different types of ANCA-associated vasculitis (AAV) that primarily affects small blood vessels of the kidneys, lungs, sinuses, and other organs.
Genentech said that FDA has approved its drug based on the results of PePRS study, a Phase IIa, open-label, multi-centre, single-arm study to evaluate the safety, pharmacokinetics, exploratory efficacy and pharmacodynamic outcomes of Rituxan in 25 patients with active GPA or MPA.
The treatment included four weekly intravenous infusions of Rituxan in combination with a tapering course of oral glucocorticoids in newly diagnosed or relapsing active GPA or MPA paediatric patients.
The company said that the study results showed that safety profile of Rituxan was consistent in type, nature and severity with the known safety profile of Rituxan in adult patients with GPA, MPA, rheumatoid arthritis and pemphigus vulgaris.
In 2011, Rituxan has become the first and only therapy FDA approved treatment for the two rare forms of vasculitis in adults and is currently indicated for the treatment of four autoimmune conditions.