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news.Astellas Pharma has reported a death in its phase II trial of anemia drug YM311, which is being tested in patients with chronic kidney disease.
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The patient died from fulminant hepatitis, also known as acute liver failure, according to the company. Astellas is jointly developing the compound with US biotech company FibroGen, which licensed the drug to Astellas for development and marketing in Europe and Japan. FibroGen is carrying out the trial in the US.
FibroGen has reported the case to the FDA and is discussing the cause and future plan, Astellas said. Astellas and FibroGen are analyzing the case.