Big things are expected Friday for ChemoCentryx (NASDAQ:CCXI). The Food and Drug Administration has approved the company’s Tavneos (avacopan) as an adjunctive treatment for anti-neutrophil cytoplasmic autoantibody-associated vasculitis (ANCA-associated vasculitis or ANCA vasculitis).
The company out of San Carlos, Calif., says the approval comes for avacopan in combination with standard therapy. Avacopan is an orally administered selective complement 5a receptor inhibitor.
“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 CEO Thomas J. Schall,
“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.”
ANCA vasculitis is a systemic autoimmune disease in which over-activation of the complement system further activates neutrophils, leading to inflammation and eventual destruction of small blood vessels.
Avacopan is also approved for microscopic polyangiitis and granulomatosis with polyangiitis (the two main forms of ANCA-associated vasculitis) in Japan.
The regulatory decision in Europe is expected by the end of 2021.
CCXI stock is up $11.80, or 60.2% at $31.40 Friday.