FDA unexpectedly delays roxa decision, foiling FibroGen's February rollout plans
Months after analysts predicted FibroGen had an approval in the bag for its chronic kidney disease-related anemia drug roxadustat, the FDA has extended its review period another three months.
AstraZeneca, which is partnered with FibroGen on the drug, announced that the FDA has requested “further clarifying analyses of clinical data,” and moved the Dec 20 PDUFA date to March 20.
“FibroGen is working closely with the FDA, in collaboration with our partner, AstraZeneca, to support the final review of the new drug application for roxadustat,” FibroGen CEO Enrique Conterno said in a statement. He told Endpoints News earlier this week that the company had been planning for a February rollout if the drug were approved.
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