FDA Delays Decision on AstraZeneca/Fibrogen’s Roxadustat for CKD Anemia

On March 1, AstraZeneca and FibroGen announced that the FDA had requested a last-minute advisory committee (AdCom) meeting to review roxadustat’s new drug application (NDA) in chronic kidney disease (CKD) anaemia. The announcement came as a surprise, as the drug’s revised PDUFA date was imminent. The FDA had previously extended the NDA’s initial review period by three months, setting an action date of March 20, 2021. Roxadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI). Despite the uncertainty triggered by the news, GlobalData believes a decision for an AdCom to be held does not translate negatively to the drug’s chances for a successful FDA approval; rather, the AdCom will most likely shed more light on roxadustat’s potential safety over current standard-of-care injectable erythropoiesis-stimulating agents (ESAs).

There are currently three HIF-PHIs currently in late-stage development in the US, including Akebia’s vadadustat and GlaxoSmithKline’s daprodustat. All three HIF-PHIs have already gained approval in Japan while roxadustat has also been approved in China. The decision for convening an AdCom is more likely related to the FDA deciding to take a more cautious stance given that roxadustat is the first drug of its class to be reviewed by the FDA. Importantly, current standard-of-care ESAs have historically been associated with increased risks of cardiovascular safety events, prompting the FDA numerous times to strengthen their safety information. Cardiovascular safety, however, has also been a topic of investigation for HIF-PHIs. For example, while roxadustat has demonstrated a non-inferior safety to placebo in non-dialysis dependent (NDD) patients in pooled analyses of data from six global pivotal Phase III trials, the competing HIF-PHI vadadustat failed to meet the primary safety endpoint, defined as non-inferiority of vadadustat versus darbepoetin alfa in time to the first occurrence of a major adverse cardiovascular event (MACE) in the Phase III PRO2TECT trial in NDD patients. Topline results of this study were presented in September 2020, shortly before roxadustat’s initial December PDUFA date. While roxadustat will likely secure approval in both NDD and dialysis-dependent (DD) patients based on favourable data, the AdCom will also guide the FDA’s decision on the drug’s precise labelling.

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The novel class is seen as a promising new addition to the treatment of CKD anaemia due to the several potential benefits they confer against current ESAs, mainly their oral route of administration. If approved in the US, HIF-PHIs are expected to put pressure on ESAs such as Amgen/J&J’s Epogen/Procrit (epoetin alfa), Amgen’s Aranesp (darbepoetin alfa) and Roche’s Mircera (methoxy polyethylene glycol-epoetin beta). However, longer-term safety data will determine the extent of their impact on ESA patient shares and solidify their position within the CKD anaemia treatment paradigm.

Roxadustat was approved in China in 2018 and 2019 in DD and NDD adult patients, respectively. In Japan, the drug was approved in 2019 and 2020 in DD and NDD, respectively.

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