FDA OKs Rituximab Label Update for 2 Rare Forms of Vasculitis


The updated label changes include information regarding use of rituximab as a follow up treatment in adults with 2 rare forms of vasculitis.

Officials with the FDA have approved a label update for rituximab (Rituxan, Genentech) to include use as a follow up treatment in adult patients for 2 rare, potentially life-threatening blood vessel disorders in adults, according to a press release.

The updated label includes information for the follow up treatment of patients with granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) who have achieved disease control with induction treatment, Genentech announced.

Rituximab was approved by the FDA in 2011 for use in combination with glucocorticoids (GCC) for the treatment of adults with GPA and MPA, with the precaution that limited data were available on the safety and efficacy of subsequent courses of rituximab in patients with GPA and MPA and that safety and efficacy of retreatment had not been established. With this new update, the precaution has been removed from rituximab’s prescribing information.

GPA and MPA are 2 types of ANCA-associated vasculitis (AAV), which primarily affects small blood vessels, according to the release. GPA and MPA can affect the small blood vessels of the kidney, lungs, sinuses, and other organs. Both diseases have a poor prognosis if left untreated.

The new update is based on data from the MAINRITSAN trial, a Roche-supported clinical trial conducted by the French Vasculitis Study Group, which used the Roche-manufactured, European Union-approved rituximab. The trial evaluated the efficacy and safety of rituximab compared with azathioprine as follow-up treatment in 115 patients who had achieved disease control after induction of remission with GCC and cyclophosphamide.

According to the data, major relapse occurred in 5% of patients taking rituximab compared with 29% of azathioprine-treated patients by month 28.

“Options for continued treatment with GPA and MPA, chronic autoimmune diseases in which patients experience periods of flares, are currently limited,” Sandra Horning, MD, chief medical officer and head of Global Product Development, said in the press release. “As part of our commitment to support people living with rare diseases, we are pleased to provide updated prescribing information for Rituxan to help physicians make more informed decisions about therapeutic options for patients who have achieved disease control with induction treatment.”

Rituximab is also used in combination with methotrexate to reduce the signs and symptoms of moderate-to-severely active rheumatoid arthritis in adults, after treatment with at least 1 other tumor necrosis factor antagonist has been ineffective, according to the prescribing information.


FDA Approves Label Update for Genentech’s Rituxan (Rituximab) in Two Rare Forms of Vasculitis [news release]. Genentech’s website. https://www.gene.com/media/press-releases/14757/2018-10-19/fda-approves-label-update-for-genentechs. Accessed October 19, 2018.

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