Easing concerns, FibroGen, AstraZeneca secure FDA date for their anemia drug in broad chronic kidney disease population
Armed with a new chief following the unexpected passing of longtime CEO Thomas Neff last year, FibroGen is off to the races with its controversial AstraZeneca-partnered anemia drug. The FDA has accepted the company’s application to market the oral therapy — which is positioned to replace the standard of care — in patients with chronic kidney disease regardless of dialysis status.
The drug, roxadustat, which is designed to stimulate the production of red blood cells by mimicking the effect of high altitude in humans was approved in China last year — marking perhaps the first instance of a multinational pharmaceutical company AstraZeneca paving the way for the sale of a medicine in China, before the United States or Europe.
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