Days after FibroGen and AstraZeneca scored their first approval for roxadustat — in China — the partners say they have more Phase III data to support their upcoming pitches in the US and other countries.
The anemia drug hit the primary endpoints of both OLYMPUS and ROCKIES: A statistically significant improvement in mean change from baseline in Hb levels averaged over weeks 28 to 52.
The two trials differ in two main aspects: In OLYMPUS, the chronic kidney disease patients are not dependent on dialysis, and the comparator arm consists of a placebo; while ROCKIES involve dialysis-dependent patients and compares roxadustat against epoetin alfa, an analog of the naturally occurring erythropoietin.
Content to learn that the trials met their primary endpoint as expected, Leerink’s Geoffrey Porges offered this take:
Today’s press release did not give any clues about the safety or tolerability of roxadustat in these two large trials (per expectation); however, the obviously robust efficacy and AstraZeneca’s recent promotional activity on social media certainly are comforting as we head into 2019 and this massive binary result.
FibroGen saw its stock $FGEN rise 8% after the news.
Roxadustat stimulates the production of red blood cells by mimicking the effect of high altitude in humans. Akebia is developing a rival HIF-PHI or hypoxia-inducible factor prolyl hydroxylase inhibitor, with a similar timeline on its own slate of pivotal studies.
FibroGen and AstraZeneca won first-mover advantage two days ago — marking the first time a top global pharma secured approval for a potential blockbuster drug in China before even filing in the United States or Europe — and opening up a sales opportunity estimated between $300 million to $1 billion. While the approval only covers dialysis-dependent patients, the companies expect to expand the label — as well as launching the drug — in 2019.
Also expected in 2019: a safety analysis that will pool results from several trials, which will also address major adverse cardiovascular event outcomes.
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