Mar 3, 2021 10:50am
The FDA has sent a last-minute notification of an advisory committee review of FibroGen and AstraZeneca s first-in-class anemia candidate roxadustat, threatening another decision delay. (FDA)
FibroGen and AstraZeneca already endured a delay in the U.S. review of their anemia candidate roxadustat. Just as the pair was expecting to snag its first-in-class approval, as the revised date draws near, a capricious FDA has stunned the companies with a second blow.
The FDA will convene an advisory committee to review roxadustat’s application for treating anemia caused by chronic kidney disease, both in patients who require dialysis and those who don’t, the two companies said Monday.
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