ChemoCentryx has pulled a filing for conditional approval of its treatment for active anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis. The biotech said it withdrew the submission for C5aR antagonist avacopan as it now expects to have the data to file for a full approval next year.
Originally, ChemoCentryx planned to bring avacopan to market in Europe on the strength of 12-week phase 2 data on 67 people with ANCA-associated vasculitis, a group of rare diseases characterized by the destruction and inflammation of small vessels in organs including the kidney and stomach. The regulatory strategy took advantage of Europe’s conditional marketing authorization (CMA) pathway.
That strategy is now on the scrapheap. ChemoCentryx attributed the shift to events that have led it to bring forward the date by which it expects to have phase 3 data to support a full filing.
“The pace of the worldwide [phase 3] ADVOCATE trial enrollment was considerably greater than originally anticipated when we applied for the European CMA,” ChemoCentryx CEO Thomas Schall said in a statement.
ChemoCentryx now expects to have top-line phase 3 data by the end of the year, setting it up to file for approval in the U.S. and Europe in 2020. Schall said the new regulatory strategy will enable “a more consistent set of filings in Europe and the U.S.”
While Schall and ChemoCentryx framed the shift as a positive, there is a downside to the change. By November 2018, ChemoCentryx’s CMA filing had already advanced past the Day 120 question stage, putting the biotech on a path that could have led to a positive opinion from the European Medicines Agency in the coming months.
Under the new plan, ChemoCentryx will need to wait until 2020 or later to get a positive opinion, depriving it of about a year of sales. Despite that, ChemoCentryx has been mulling the value of the CMA for months. Talking to investors in November, Schall said the proximity of the anticipated CMA decision and phase 3 data presented ChemoCentryx with an “interesting conundrum.”