FibroGen Settles with SEC for $1.25M Over Roxadustat Data Tampering Allegations
FibroGen agreed to pay $1.25 million to the U.S. Securities and Exchange Commission (SEC) to settle allegations related to manipulated clinical trial data for its anemia drug roxadustat15.
The SEC alleged that from November 2019 to March 2021, former FibroGen Chief Medical Officer Dr. Kin-Hung Peony Yu 'reverse engineered' phase 3 trial data to make roxadustat appear superior in cardiovascular safety compared to the existing treatment epoetin alfa, when the original results showed only comparable efficacy13.
Dr. Yu reportedly applied post hoc changes to stratification factors during data analysis and presented the manipulated results as superior in multiple forums, including press releases, earnings calls, SEC filings, and a peer-reviewed journal article13.
FibroGen management issued a corrective disclosure in April 2021, admitting the use of post-hoc changes and presenting the less favorable original results3.
While FibroGen has settled with the SEC, Dr. Yu is facing separate charges from the Commission for making false and misleading public statements regarding the cardiovascular safety of roxadustat3.
Roxadustat has since faced regulatory setbacks, with the FDA rejecting its approval for chronic kidney disease anemia in the U.S., although it remains approved in China and South Korea under the brand name Evrenzo14.
AstraZeneca, FibroGen's development partner, returned U.S. and some other regional rights for roxadustat in 2024 but retains interest in China and South Korea1.
Sources:
1. https://www.fiercebiotech.com/biotech/fibrogen-pays-sec-12m-over-allegations-former-exec-reverse-engineered-roxadustat-data
3. https://www.sec.gov/enforcement-litigation/litigation-releases/lr-26394
4. https://www.fiercepharma.com/pharma/fibrogen-settles-kind-pharma-former-employees-accused-pinching-trade-secrets-experimental
5. https://www.law360.com/healthcare-authority/policy-compliance/articles/2385232/fibrogen-to-pay-sec-1-25m-over-drug-mistatements