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FDA advisory committee votes against approval of AZ, FibroGen's roxadustat

Briefing documents published earlier this week raised questions over the safety profile of roxadustat

A US Food and Drug Administration (FDA) advisory committee has voted against approval of AstraZeneca (AZ) and FibroGen’s roxadustat for the treatment of anaemia in chronic kidney disease (CKD) patients.

The FDA’s cardiovascular and renal drugs advisory committee (CRDAC) has voted 13 to one that the benefit-risk profile of roxadustat does not support approval for the treatment of anaemia in non-dialysis dependent (NDD) CKD patients.

The committee also voted 12 to two that the benefit-risk profile of the drug does not support approval for the treatment of anaemia in dialysis-dependent (DD) CKD patients.

Although the FDA is not bound to following the recommendations made by the advisory committee, it usually does so.

The CRDAC outcome is not surprising, after briefing documents published ahead of the committee meeting earlier this week raised questions over the safety profile of roxadustat for the treatment of anaemia in CKD patients.

During the meeting, members of the CRDAC discussed the safety and efficacy profile of roxadustat in both NDD and DD CKD patients, as well as the enrolment criteria for the clinical research programme, a potential post-marketing study and more.

The committee members concluded that AZ and FibroGen should produce additional safety data for roxadustat in this indication prior to marketing of the drug.

According to analysis included in the FDA briefing documents, roxadustat was comparable to epoetin alfa, a standard therapy for anaemia in CKD, on the composite measure of major adverse cardiovascular events (MACE).

However, the FDA raised concerns over serious thrombotic events and seizures with roxadustat treatment, which were detected against a placebo background in the NDD patient population and evident against epoetin alfa, “which is itself known to pose these risks”.

“New solutions are needed for the six million people in the US affected by anaemia of chronic kidney disease,” said Mene Panagalos, executive vice president, BioPharmacetucials R&D at AZ.

“Although we are disappointed by today’s outcome, we will continue to work closely with our partner FibroGen and the FDA to determine the path forward for roxadustat,” he added.

AZ added in a statement that the FDA has not yet revealed when it will make a final decision on the new drug application (NDA) for roxadustat.

Article by
Lucy Parsons

16th July 2021

From: Regulatory



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