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FDA Approves First Drug To Treat Pediatric GPA And MPA

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Vasculitis, which refers to inflammation of the blood vessels, is an autoimmune disease wherein the immune system attacks the body's own cells for unknown reasons. There are approximately 20 different disorders that are classified as "vasculitis". (Source: Johns Hopkins Vasculitis Center).

Rituxan, developed by Roche's Genentech, was approved by the FDA on September 27, 2019, for the treatment of two types of vasculitis in children - Granulomatosis with Polyangiitis (GPA, formerly known as Wegener's) and Microscopic Polyangiitis in children 2 years of age in combination with glucocorticoids.

Granulomatosis with polyangiitis (GPA), formerly known as Wegener's granulomatosis, and Microscopic Polyangiitis (MPA) are both rare disorders characterized by blood vessel inflammation, primarily affecting small blood vessels of the kidneys, lungs, sinuses, and a variety of other organs, but the diseases may affect each person differently. However, unlike GPA, Microscopic Polyangiitis does not cause granuloma formation.

Rituxan becomes the first drug to be approved in the U.S. for pediatric GPA and MPA. The drug was approved to treat adult patients with GPA and MPA in 2011.

Besides GPA and MPA, non-Hodgkin's lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, and pemphigus vulgaris are the other indications for which Rituxan is approved. The drug brought home sales of CHF 6.752 billion for Roche in 2018.

Both GPA and MPA are considered rare diseases, with an estimated prevalence in the United States of up to 3 cases per 100,000 people. Cases of pediatric-onset GPA and MPA are even rarer and are associated with severe, potentially life-threatening symptoms.

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