FibroGen shocked investors this week by admitting that it changed data in a drug study to make its safety profile appear more favorable.
The drug, roxadustat, is a first-in-class therapy developed to treat anemia in patients with chronic kidney disease that’s currently under review by the FDA. In a statement this week, the company disclosed that it made post-hoc changes to phase 3 trial data that impacted stratification factors among the study’s patients subgroups.
In the phase 3 data originally presented to investors, the drug seemed to have lower cardiovascular risks than the current standard of care. Yet, the new analysis shows that it is not safer for incident dialysis patients.
Although the post-hoc changes only impact that patient group, it takes away one of the prime selling points for the new drug.
The company asserts that the risk/benefit profile of the drug still supports approval, but the news rattled investors and has triggered talk of potential lawsuits.
An FDA advisory committee meeting on roxadustat, which has already been approved in China and Japan, has been scheduled for July 15.
Read the Barron’s report.
