UPDATED: AstraZeneca, FibroGen flag appealing pooled safety data on roxa for key segment of the CKD market
AstraZeneca rolled out its pooled hazard ratios on roxadustat safety today, which helps map out how they plan to take on the huge anemia market for chronic kidney disease patients who have relied on EPO for decades — provided the FDA comes through with an OK.
The basic breakdown has to address 2 different regulatory standards, using MACE for the FDA and MACE+ for European regulators, where guidelines add congestive heart failure and angina hospitalizations to the mix of cardio threats. Researchers have already outlined appealing efficacy numbers. But AstraZeneca’s partner — FibroGen — spooked analysts and investors back in May when they fudged the top-line statement indicating there could be real trouble in key market segments. The partners, though, appear to have skirted the worst-case scenario underscored by a recent short attack, expecting that key hazard ratios could scuttle the drug entirely.
There was a clear step up in risk as investigators assessed the drug against placebo for non-dialysis CKD patients, against EPO in dialysis patients, and against a population of patients new-to-dialysis, called incident dialysis.
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