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FDA Approves Rituxan for Treatment of Wegener's Granulomatosis and Microscopic Polyangiitis

Strategic Insights

— 2 min read

The U.S. Food and Drug Administration (FDA) has approved Rituxan, a therapeutic antibody, in combination with corticosteroids, as a new medicine for adults with Wegener's Granulomatosis (WG) and Microscopic Polyangiitis (MPA). These rare autoimmune diseases affect the small blood vessels of the kidneys, lungs, sinuses, and other organs, and are characterized by inflammation associated with autoantibodies called ANCAs. Rituxan has been shown to be not inferior to the current standard of care, cyclophosphamide, in inducing disease remission at six months in adults with WG and MPA.

Key Takeaways:

  • The FDA approval of Rituxan is based on a National Institutes of Health-sponsored study known as RAVE, which showed that Rituxan was not inferior to the current standard of care, cyclophosphamide, in inducing disease remission at six months in adults with WG and MPA.
  • Rituxan has been approved for the treatment of Wegener's Granulomatosis and Microscopic Polyangiitis in adults, and is the first medicine to be approved specifically for the treatment of these rare and relapsing diseases.
  • The RAVE study was a multicenter, randomized, double-blind, active-controlled study that involved 197 patients with WG and MPA who received either Rituxan or cyclophosphamide with corticosteroids.
  • The primary endpoint of the study was complete remission at six months, which was achieved by 64% of patients in the Rituxan group and 53% of patients in the cyclophosphamide group.
  • The most common side effects of Rituxan were infections, nausea, diarrhea, headache, muscle spasms, anemia, and peripheral edema.
  • Rituxan is not recommended for use in patients with severe, active infections.
  • The approval of Rituxan for the treatment of WG and MPA is an important example of how the scientific community can work together to advance science and treatment options for orphan diseases.

Statistics:

  • 64% of patients in the Rituxan group achieved complete remission at six months, compared with 53% of patients in the cyclophosphamide group.
  • The RAVE study involved 197 patients with WG and MPA from across the United States.
  • The peak age range of onset for WG and MPA is 65 to 74 years.
  • Males are typically affected as often as females.

Sources:

  • FDA Press Release: FDA Approves Rituxan for Treatment of Wegener's Granulomatosis and Microscopic Polyangiitis (April 19, 2010)
  • National Institutes of Health: RAVE Study (ClinicalTrials.gov Identifier: NCT00022705)
  • Genentech Press Release: Genentech Announces FDA Approval of Rituxan for Treatment of Wegener's Granulomatosis and Microscopic Polyangiitis (April 19, 2010)
  • Biogen Idec Press Release: Biogen Idec and Genentech Announce FDA Approval of Rituxan for Treatment of Wegener's Granulomatosis and Microscopic Polyangiitis (April 19, 2010)

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