ChemoCentryx Gains Runway To Grow With Avacopan Approval
ChemoCentryx gets US approval of Tavneos for ANCA vasculitis, which it says may gradually ramp up to a blockbuster revenue opportunity. Current steroid-heavy standard of care has many drawbacks.
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Near tie goes to the US FDA? While almost every member of the Arthritis Advisory Committee agreed with agency’s assessment that ChemoCentryx’s trial of avacopan for ANCA vasculitis was poorly designed, making it hard to tease out the drug’s benefit-risk profile, about half were in favor of approval due to the potential to spare patients from the adverse effects of steroids. Others said the sponsor didn’t meet the agency’s standard for approval off just one pivotal study.
With biosimilars to Avastin on the way later this year in Europe, Roche will face competition to its three key biosimilar monoclonal antibodies in the US, EU and Japan. Management detailed to investors the company’s latest expectations.
The company and partner Vifor said the selective complement 5a receptor inhibitor met both primary and multiple secondary endpoints; US and EU filings are planned for 2020.