Following an evenly split vote from the US regulator’s advisory committee in May this year, there was good news for US biotech ChemoCentryx (Nasdaq: CCXI) on Friday, as the US Food and Drug Administration approved the firm’s Tavneos (avacopan), an orally administered selective complement 5a receptor inhibitor, propelling its shares 69% higher to $33.13.
Tavneos is cleared as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis (also known as ANCA-associated vasculitis or ANCA vasculitis), specifically granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) (the two main forms of ANCA vasculitis), in combination with standard therapy.
“Today is a momentous day in the history of ChemoCentryx; the culmination of decades of effort aimed at offering new hope to patients with this and other debilitating and deadly diseases,” said Thomas Schall, president and chief executive of ChemoCentryx. “We look forward to making Tavneos available to clinicians and patients in the next few weeks. We thank the agency for their collaboration and consideration and we are also immensely grateful to the pioneering scientists, clinicians and patients who believed in the promise of Tavneos and who have worked tirelessly to make it a reality, along with my dedicated and talented colleagues at ChemoCentryx,” he added.
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