ChemoCentryx’s Tavenos Wins FDA Approval

ChemoCentryx has secured FDA approval for oral Tavenos (avacopan) as an adjunctive therapy for adults with a potentially fatal autoimmune disease characterized by overactivation of the complement system.

The approval of the drug for treatment of severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis (ANCA) came despite the agency’s arthritis advisory committee stalemating in a 9-9 vote over the drug’s approval.

Some members of the expert panel questioned the magnitude of any treatment effect, wondering if the drug’s only real clinical benefit is its ability to reduce steroid usage in ANCA patients. Others argued that reducing steroid dependency is an important therapeutic goal in and of itself.

The company’s phase 3 pivotal trial met its primary endpoints of disease remission at 26 weeks and sustained remission at 52 weeks.