medwireNews: The EMA has recommended approval of avacopan, when used in combination with rituximab or cyclophosphamide, for the treatment of two forms of antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis.
The complement 5a receptor inhibitor may now be given to adult patients with severe, active granulomatosis with polyangiitis or microscopic polyangiitis.
This announcement is based on data from the phase 3 ADVOCATE trial, which evaluated the efficacy of avacopan in combination with standard therapy regimens in patients with ANCA-associated vasculitis.
Avacopan was designated as an orphan medicine – defined as a drug to treat a life-threatening or chronically debilitating rare condition (affecting ≤ 5 per 10,000 people in the European Union) or a drug that is unlikely to generate enough profit to justify development costs – during its development. Following the recommendation for approval, the EMA will assess whether this orphan designation should be maintained.
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