ChemoCentryx Inc (NASDAQ: CCXI) shareholders had every reason to be happy about on Friday morning. The shares of the group traded higher on Friday morning, thanks to the announcement made by the group. The company announced that it had received the U.S. Food and Drug Administration (FDA) approval for its TAVNEOS.
TAVNEOS is the debut FDA approved orally-administered inhibitor with C5a receptor
According to sources from the company, TAVNEOS is the first orally administered inhibitor with the C5a receptor, which has received the FDA nod. The approval came after the results of the crucial ADVOCATE Phase III trial were analyzed. In The New England Journal of Medicine (NEJM), February 2021 edition, the research trial received visibility.
The group has designed, developed, and implemented TAVNEOS Connect, an initiative to help and guide patients who have been prescribed TAVNEOS.
Details about the study and results
As part of the respective study, the subjects were divided into two groups. While one set of the samples received rituximab or cyclophosphamide, another set was administered with TAVNEOS or oral prednisone. Depending on the need, the subjects in both groups were eligible to receive protocol glucocorticoids. As declared by the Birmingham Vasculitis Activity Score, or BVAS, the study sustained a temporary diminution of the severity of disease or pain in the 52nd week.
About 330 patients with associated vasculitis syndrome from 20 countries participated in phase III of the trial. Also known as ANCA vasculitis, associated vasculitis syndrome is an autoimmune condition that affects the small blood vessels in the body.
ChemoCentryx to commercialize in U.S.
ChemoCentryx is a statement informed that the group is responsible for discovering and implementing TAVNEOS (avacopan). The commercial rights for the drug in the U.S. are also in the hands of the group. Meanwhile, ChemoCentryx’s Kidney Health Alliance and Vifor Pharma have provided Vifor Pharma the individual rights to commercialize TAVNEOS in markets beyond the borders of the U.S. TAVNEOS (avacopan) is used to treat adults who suffer from severe active anti-neutrophil cytoplasmic autoantibody (ANCA).
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