ChemoCentryx Soars On Phase III Avacopan Data In ANCA Vasculitis
The company and partner Vifor said the selective complement 5a receptor inhibitor met both primary and multiple secondary endpoints; US and EU filings are planned for 2020.
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Phase III trial was statistically significant, but US FDA argues complex study design makes it unclear that ChemoCentryx’s avacopan offers a clinically meaningful benefit, including a safety advantage, for ANCA vasculitis. Agency had tried to direct company to better designed trials earlier in development program.
Stefan Schulze, CEO of the Swiss iron deficiency and kidney disease specialist, tells Scrip that Vifor's reputation as a go-to industry partner should result in at least two more licensing deals or product acquisitions in 2021.