ChemoCentryx Files Amendment to Avacopan NDA

By Chris Wack

ChemoCentryx Inc. said that, following consultations with the U.S. Food and Drug Administration, it filed an amendment to its New Drug Application for avacopan for the treatment of anti-neutrophil cytoplasmic autoantibody-associated vasculitis.

The company said the amendment addresses points raised during an FDA Advisory Committee meeting on May 6.

The FDA has indicated that the filing constitutes a major amendment to the NDA and will result in the setting of a new Prescription Drug User Fee Act goal date of Oct. 7. The NDA is primarily based on data from a Phase III trial of avacopan for the treatment of ANCA-associated vasculitis.

On May 6, the FDA's Arthritis Advisory Committee voted 9-9 on whether the efficacy data support approval of avacopan, 10-8 that the safety profile of avacopan is adequate to support approval, and 10-8 that the benefit-risk profile is adequate to support approval of avacopan at the proposed dose of 30 mg twice daily.

The Marketing Authorization Application for avacopan in the treatment of ANCA-associated vasculitis was validated by the European Medicines Agency in November 2020, and the Japanese New Drug Application was accepted for review by the Japanese Pharmaceuticals and Medical Device Agency in February.

ChemoCentryx shares were up 8% to $14.30 in premarket trading.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

July 06, 2021 09:42 ET (13:42 GMT)

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