Nucala Approved for EGPA/CSS Treatment

GlaxoSmithKline (GSK) achieves approval for Nucala (mepolizumab) for the treatment of eosinophilic granulomatosis with polyangiitis (EGPA) for adults in the US

December 13, 2017:  GSK announced that the US Food and Drug Administration (FDA) has approved Nucala (mepolizumab) as the first targeted treatment for eosinophilic granulomatosis with polyangiitis (EGPA), previously known as Churg-Strauss syndrome.

The approval for EGPA is based on results from the pivotal, 52-week, Phase III MIRRA1 study, conducted as a collaboration between GSK and the National Institute of Allergy and Infectious Diseases, part of the US National Institutes of Health.

The approval for EGPA is based on results from the pivotal, 52-week, Phase III MIRRA1 study, conducted as a collaboration between GSK and the National Institute of Allergy and Infectious Diseases, part of the US National Institutes of Health.

Joyce Kullman, executive director of the Vasculitis Foundation (VF), said, “Nucala is the first FDA-approved drug for treatment of EGPA/Churg-Strauss Syndrome vasculitis, and the VF is delighted for our patients and their families.  EGPA (CSS) is a chronic illness and patients often face repeated relapses, which can cause serious health problems.  We are hopeful that Nucala will enable many more of our patients to achieve longer remission with a greater quality of life.”

Read the full press release from GlaxoSmithKline at: http://bit.ly/2BvJznz

 

 

Vasculitis Foundation

The Vasculitis Foundation is the international organization for patients with vasculitis, their families, friends and the health care professionals who care for them.