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EU: Vifor Tries Again With Avacopan Using ‘More Powerful’ Data

US Filing Was Submitted In September

 
• By Neena Brizmohun

Vifor Pharma has resubmitted a marketing application for avacopan to the European Medicines Agency – this time for an unconditional approval.

People, health care and medicine concept - unhappy man suffering from pain in back or kidneys sitting on bench on street
ANCA-associated vasculitis is a group of rare kidney autoimmune diseases • Source: Shutterstock

Vifor Pharma is having another go at securing EU marketing approval for avacopan, its investigational treatment for ANCA-associated vasculitis, a group of rare kidney autoimmune diseases that lead to significant morbidity and mortality.

The Swiss company pulled its original application for a conditional marketing authorization (CMA) for avacopan nearly two years ago. It...

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