EU Approves ChemoCentryx’ Tavenos for ANCA-Associated Vasculitis
January 19, 2022
The European Union approved ChemoCentryx’ Tavenos in combination with a rituximab or cyclophosphamide regimen for the treatment of adult patients with severe, active granulomatosis polyangiitis or microscopic polyangiitis, the two main forms of ANCA-associated vasculitis.
The approval follows the U.S. Food and Drug Administration approval of Tavenos in October 2021. Tavenos will receive marketing authorization in all member states of the European Union, as well as in Iceland, Liechtenstein, and Norway.
“European Union approval of Tavenos represents the third major global sector to recognize the value of this long-awaited new treatment for the debilitating and often deadly disease of ANCA-associated vasculitis,” said Thomas Schall, president and CEO of ChemoCentryx.
ANCA-associated vasculitis is a systemic disease in which over-activation of the complement pathway further activates neutrophils, leading to inflammation and destruction of small blood vessels. This results in organ damage and failure, with the kidney as the major target, and is fatal if not treated. Currently, treatment for ANCA-associated vasculitis consists of courses of non-specific immuno-suppressants, combined with the administration of daily steroids for prolonged periods of time, which can be associated with significant clinical risk including death from infection.
Tavneos is a first-in-class, orally administered small molecule that employs a novel, highly targeted mode of action in the treatment of ANCA-associated vasculitis and other complement-driven autoimmune and inflammatory diseases. By precisely blocking the receptor for the pro-inflammatory complement system fragment known as C5a on destructive inflammatory cells, such as blood neutrophils, Tavneos arrests the ability of those cells to do damage in response to C5a activation, which is known to be the driver of ANCA-associated vasculitis.
As part of their Kidney Health Alliance, ChemoCentryx retains all rights for Tavenos for orphan and renal diseases in the United States and Vifor Pharma has rights to commercialize Tavneos in the rest of the world. Vifor will pay ChemoCentryx royalties in the teens to the mid-20s percent on potential ex-U.S. sales of one aggregate net sales line.
ChemoCentryx is also developing Tavneos for the treatment of patients with C3 glomerulopathy, hidradenitis suppurativa, and Lupus Nephritis. The U.S. Food and Drug Administration granted Tavneos orphan drug designation for ANCA-associated vasculitis and C3G. The European Commission has granted orphan medicinal product designation for Tavneos for the treatment of two forms of ANCA-associated vasculitis: microscopic polyangiitis and granulomatosis with polyangiitis (formerly known as Wegener’s granulomatosis), as well as for C3G.
Author: Rare Daily Staff
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