On December 13, 2017, GSK announced that the U.S. Food and Drug Administration (FDA) approved Nucala (mepolizumab) as the first targeted treatment for eosinophilic granulomatosis with polyangiitis (EGPA), previously known as Churg-Strauss syndrome (CSS).
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 U.S. 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.
“The true champions are the dedicated patients who participated in the study trials and the many scientists committed to improving treatments for our patients. We are grateful for all their efforts to improve the lives of other patients with EGPA, and future patients with the diagnosis. Until we discover a cure, we must work to develop more effective treatments to help all of our patients living with vasculitis.”
Nucala was the second drug approved by the FDA for the treatment of vasculitis in 2017. In May 2017, Atermra received approval to treat giant cell arteritis. This brings to a total, three drugs approved by the FDA since 2010 for vasculitis.
Read the full press release from GlaxoSmithKline at: http://bit.ly/2BvJznz