The FDA to treatment of eosinophilic granulomatosis with polyangiitis (EGPA) in adults, making it the first drug specifically approved for that disease.
EGPA, formerly known as Churg-Strauss syndrome, is one of the rarest systemic vasculitis conditions, affecting 10.7 to 14 per million adults. The autoimmune condition causes inflammation in small- to medium-sized blood vessels and is often characterized by late-onset asthma, blood eosinophilia, and skin nodules or purpura.
Mepolizumab, a monoclonal antibody that binds to interleukin-5 to keep it from binding to receptors on the surface of eosinophils, had previously been approved for severe eosinophilic asthma.
"The expanded indication of Nucala meets a critical, unmet need for EGPA patients," Badrul Chowdhury, MD, PhD, of the FDA's Center for Drug Evaluation and Research, said in a release from the agency. "It's notable that patients taking Nucala in clinical trials reported a significant improvement in their symptoms."