Fibrogen $FGEN and AstraZeneca $AZN took a big step toward completing their new drug application in China for the anemia drug roxadustat after hitting the primary endpoints in two Phase III studies in the key Asian market.
Chronic kidney disease patients taking roxadustat (FG-4592 or 罗沙司他) gained a mean average of 1.9g/dL in hemoglobin levels, compared to a drop of -0.4g/dL in the placebo group. And 84% of the patients had a significant increase in hemoglobin response, compared to none in the placebo arm.
The drug also hit the non-inferiority goal line against Kirin Epo while outperforming the industry standard in the per-protocol evaluation — 0.75g/dL vs. 0.46g/dL.
FibroGen’s shares surged about 10% on the news in pre-market trading.
If the partners get an approval in China, FibroGen plans to handle the manufacturing while AstraZeneca does the commercialization work.
FibroGen has been racing against Akebia on this front. Like FibroGen, Akebia $AKBA is also working on stimulating the production of red blood cells by mimicking the effect of high altitude on humans with vadadustat. And it hopes to tackle ESAs from Amgen, a market worth billions in annual income. The biotech struck a billion-dollar deal with Otsuka late last year.
“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,” said Tom Neff, the CEO at FibroGen. “In addition, use of roxadustat is free of the burden of cold-chain storage and maintaining sterility, and costly distribution infrastructure. Data from these two studies will be used to complete our new drug application submission in China later this year.”
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