ChemoCentryx Inc said on Friday the U.S. health agency approved its lead drug for treating a rare, fatal autoimmune disease, sending the biopharmaceutical company's shares up by more than 70%.
cancer drug Rituxan, combined with daily administration of steroids, which can cause severe side effects.
The disease affects about 40,000 people in the United States, with about 4,000 new cases each year, according to the company.The drug had received mixed reviews from an expert panel to the U.S. Food and Drug Administration in May, with the committee's vote split equally on whether the efficacy data supported the drug's approval.
Following this meeting, the company submitted additional data in July for its marketing application for avacopan., giving it the commercialization rights in the United States, while Vifor has rights for the rest of the world. The drug was approved in Japan last month and the European regulatory body could give its nod by the end of this year.Reporting by Oishee Majumdar and Dania Nadeem in Bengaluru; Editing by Rashmi Aich and Anil D'SilvaSubscribe for our daily curated newsletter to receive the latest exclusive Reuters coverage delivered to your inbox.
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