FDA Approves ChemoCentryx’s Tavenos

The approval of ChemoCentryx’s Tavenos (avacopan) provides a new treatment for active anti-neutrophil cytoplasmic autoantibody-associated vasculitis.

ChemoCentryx, a biopharmaceutical company targeting the chemokine and chemoattractant systems, announced that FDA approved Tavenos (avacopan), an orally-administered selective complement 5a receptor inhibitor, on Oct. 8th, 2021. Avacopan was approved as an adjunctive treatment for adults with severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis, also known as ANCA-associated vasculitis, in combination with standard therapy.

ANCA-associated vasculitis is a systemic autoimmune disease where over-activation of the complement system further activates neutrophils, which leads to inflammation and destruction of small blood vessels. This results in organ damage and failure, often in the kidneys, and is usually fatal if untreated. Avocapan is intended for the two main forms of ANCA-associated vasculitis—granulomatosis with polyangiitis and microscopic polyangiitis.

According to a company press release, avacopan is an orally-administered small molecule that employs a novel, highly-targeted mode of action in complement-driven autoimmune and inflammatory diseases. By blocking the complement 5a receptor (C5aR) for the pro-inflammatory complement system fragment, it can arrest the ability of those cells to do damage in response to C5a activation. This is key because this pathway is known to be the driver of ANCA vasculitis, halting detrimental effects. Additionally, it leaves the beneficial C5a pathway through the C5L2 receptor functioning normally.

“I am excited that 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,” said Peter A. Merkel, chief of rheumatology at the Perelman School of Medicine at the University of Pennsylvania, director of the international Vasculitis Clinical Research Consortium, and consultant to ChemoCentryx, in the press release. “Patients will now have access to a new class of medication that provides beneficial effects for the treatment of ANCA-associated vasculitis.”

Source: ChemoCentryx