FDA approves first drug for eosinophilic granulomatosis with polyangiitis

FDA on Monday expanded the approved use of mepolizumab (Nucala—GlaxoSmithKline) to treat adult patients with eosinophilic granulomatosis with polyangiitis (EGPA), a rare autoimmune disease that causes vasculitis, an inflammation in the wall of blood vessels of the body.

FDA on Monday expanded the approved use of mepolizumab (Nucala—GlaxoSmithKline) to treat adult patients with eosinophilic granulomatosis with polyangiitis (EGPA), a rare autoimmune disease that causes vasculitis, an inflammation in the wall of blood vessels of the body. This new indication provides the first FDA-approved therapy specifically to treat EGPA. According to NIH, EGPA is a condition characterized by asthma, high levels of eosinophils, and inflammation of small- to medium-sized blood vessels. The inflamed vessels can affect various organ systems including the lungs, gastrointestinal tract, skin, heart, and nervous system. It is estimated that approximately 0.11 to 2.66 new cases per 1 million people are diagnosed each year, with an overall prevalence of 10.7 to 14 per 1,000,000 adults. The most common adverse events associated with mepolizumab in clinical trials included headache, injection site reaction, back pain, and fatigue. The therapy should not be administered to patients with a history of hypersensitivity to mepolizumab or one of its ingredients. It should not be used to treat acute bronchospasm or status asthmaticus. Hypersensitivity reactions, including anaphylaxis, angioedema, bronchospasm, hypotension, urticaria, rash, have occurred. Patients should discontinue treatment in the event of a hypersensitivity reaction.