ChemoCentryx Inc. (NASDAQ: CCXI) stock gained by 3.91% in the current market trading. ChemoCentryx is a pharmaceutical firm focused on the development of novel treatments for inflammatory and autoimmune disorders, as well as cancer. ChemoCentryx focuses on the chemokine and chemoattractant systems in order to find, develop, and market orally-administered treatments.
What is happening?
ChemoCentryx has filed an amendment to its New Drug Application (NDA) for avacopan for the cure of Anti-neutrophil Cytoplasmic Autoantibody (ANCA)-associated vasculitis, following consultations with the US Food and Drug Administration. The amendment addresses issues made during the FDA Advisory Committee meeting on May 6, 2021. The FDA has said that the submission is a substantial modification to the NDA and that a new PDUFA goal date of October 7, 2021 would be established.The NDA is based largely on the results of the avacopan Phase III ADVOCATE study for the treatment of ANCA-associated vasculitis. The FDA’s Arthritis Advisory Committee decided 9-9 on whether avacopan’s effectiveness results warranted approval on May 6. They voted 10-8 that the safety and effectiveness of avacopan is sufficient to warrant authorization, and 10-8 that the benefit-risk profile of avacopan at the proposed dose of 30 mg twice day is adequate to support approval.
Thomas J. Schall, President and Chief Executive Officer of ChemoCentryx commented,
CCXI is grateful for the opportunity to present the Agency with new data and information, which they think answers many of the concerns highlighted during the Advisory Committee meeting. The Agency and CCXI will continue to talk in the future.
The European Medicines Agency (EMA) certified the Marketing Authorization Application (MAA) for avacopan in the cure of ANCA-associated vasculitis in November 2020, while the Japanese Pharmaceuticals and Medical Device Agency accepted the Japanese New Drug Application for evaluation in February 2021.