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By Oishee Majumdar and Dania Nadeem
October 8 (Reuters) – ChemoCentryx Inc said on Friday that the US health agency had approved its lead drug for the treatment of a rare and fatal autoimmune disease, pushing the biopharmaceutical company’s shares up by more than 70% .
The company said the drug, called avacopan and sold under the brand name Tavneos, is expected to be available to clinicians and patients in the coming weeks.
Avacopan is taken by mouth to treat vasculitis associated with cytoplasmic antineutrophil antibodies (ANCA) (AAV) – a group of conditions characterized by the destruction and inflammation of small blood vessels and affecting various organs, especially the kidneys.
It works by blocking the activity of a protein called the C5a receptor, which is responsible for many inflammatory diseases.
Current treatments for the disease include immunosuppressants such as Biogen Inc and the anticancer drug Rituxan from Roche Holding AG, combined with daily administration of steroids, which can cause serious 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.
Stifel analyst Dae Gon Ha estimates that Avacopan will generate $ 1.3 billion in revenue by 2035.
The drug had received mixed reviews from a panel of US Food and Drug Administration experts in May, with the committee’s vote evenly split on whether the efficacy data supported drug approval.
Following this meeting, the company submitted additional data for its avacopan marketing dossier in July.
The company has an exclusive licensing agreement with the Swiss company Vifor Pharma, giving it the rights to market in the United States, while Vifor holds the rights for the rest of the world.
The drug was approved in Japan last month and the European regulator could give the green light by the end of this year.
The company is also testing avacopan for other conditions, including a type of skin disease. (Reporting by Oishee Majumdar and Dania Nadeem in Bengaluru; Editing by Rashmi Aich and Anil D’Silva)
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