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FDA Approves First Drug for Rare Vasculitis (FDA)

— Nucala OK'd for eosinophilic granulomatosis with polyangiitis (EGPA)

MedpageToday

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."