The FDA has approved Tavneos, a first-in-class, oral therapy to treat a group of autoimmune diseases characterized by inflammation and damage to small blood vessels.
ChemoCentryx has chosen Amber Specialty Pharmacy to dispense Tavneos (avacopan) for the treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis.
The FDA approved Tavneos Oct. 8, 2021. It is the first of its kind orally administered selective complement 5a receptor inhibitor for this rare systemic disease in which over-activation of the complement pathway leads to inflammation and destruction of small blood vessels.
The approval was based on phase 3 data of 330 patients with ANCA-associated vasculitis in 20 countries. The study met its primary endpoints of disease remission at 26 weeks and sustained remission at 52 weeks, as assessed by the Birmingham Vasculitis Activity Score.
The most common adverse reactions were: nausea, headache, hypertension, diarrhea, vomiting, rash, fatigue, upper abdominal pain, dizziness, blood creatinine increase, and paresthesia.
“Our work has helped lead to the first-in-a-decade approval of a medicine for ANCA-associated vasculitis. This is an important step forward in the treatment of this disease,” the trial’s co-primary academic investigator Peter A. Merkel, M.D., the chief of rheumatology at the Perelman School of Medicine at the University of Pennsylvania, said in a statement. “Patients will now have access to a new class of medication that provides beneficial effects for the treatment of ANCA-associated vasculitis.”
ANCA-associated vasculitis is a rare disease with an estimated prevalence of 200 to 400 cases per million people and is more prevalent in middle-age white men and women. The incidence has increased over time, likely due to improvements in diagnosis.
ChemoCentryx has developed TAVNEOS Connect, a patient support program. To learn more visit the website here.