Phase 3 hit tees FibroGen, AstraZeneca up for anemia filing

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FibroGen is aiming to complete an NDA in China later this year.

FibroGen has posted positive phase 3 data on its AstraZeneca-partnered anemia drug. Both trials in the Chinese phase 3 program met their primary endpoints, moving FibroGen closer to filing for approval of a drug that enjoys fast-track status in the country.

The first of the phase 3 trials enrolled 151 anemia patients and randomized them to receive either FibroGen’s oral HIF-PH inhibitor roxadustat or a placebo. Hemoglobin levels in the treatment arm increased by 1.9 g/dL over the course of the eight-week trial. Levels fell by 0.4 g/dL in the placebo cohort, resulting in the study meeting its primary endpoint. The trial also hit a secondary endpoint that looked at the proportion of patients whose hemoglobin levels increased by 1 g/dL or more.

FibroGen enjoyed similar success in the second phase 3 trial. That study gave roxadustat or epoetin alfa (EPO) to 271 hemodialysis and 33 peritoneal dialysis patients. FibroGen matched up to EPO in terms of change in hemoglobin from baseline and, as such, the study met its primary endpoint.

When paired to other favorable characteristics of roxadustat, FibroGen thinks the data give it a shot at winning approval in China—a country with a sizable predialysis population—and going on to claim a slice of the market for treating anemia in dialysis-dependent and non-dialysis-dependent chronic kidney disease.

“We are very encouraged by the topline results of these two pivotal Phase 3 studies for roxadustat, which bring us closer to the first oral anemia therapy that does not require injectable administration or IV iron supplementation. In addition, use of roxadustat is free of the burden of cold-chain storage and maintaining sterility, and costly distribution infrastructure,” FibroGen CEO Tom Neff said in a statement.

FibroGen plans to use data from the two studies to complete a rolling new drug application in China later this year. Having secured a place on China’s fast-track “green channel” last year, roxadustat has a shot at making its way through the country’s regulatory process unusually quickly, although it is unclear exactly how long it will take. If approved, FibroGen will handle manufacturing, leaving AstraZeneca to focus on the launch and commercialization.

Shares in FibroGen rose more than 7% in premarket trading.