FibroGen and partner AstraZeneca have yet to figure out an FDA path for their once-rejected anemia drug roxadustat. And now, another regulator is piling into the mess.
FibroGen received a subpoena from the U.S. Securities and Exchange Commission (SEC) in the fourth quarter of 2021, the biotech disclosed in a filing (PDF) Monday. The securities watchdog is asking for documents related to roxadustat’s pooled cardiovascular safety data.
“We have been fully cooperating with the SEC’s investigation,” FibroGen said. The company will update investors “at the appropriate time” as it learns more, CEO Enrique Conterno said during a call about the firm’s fourth-quarter performance.
The company didn’t articulate the exact nature of the probe, but the SEC could be taking an interest in the possibility of foul play in FibroGen’s disclosures of roxadustat’s heart safety data, which has caused major fluctuations in the California company’s stock price.
FibroGen and AZ were angling for roxa to be a possible first-in-class oral drug to treat anemia caused by chronic kidney disease. One key measurement of the drug’s market potential lies in its heart safety profile, an area where existing therapies have less-than-ideal performance.
Peak sales projections for roxa had been flying high after FibroGen and AZ unveiled in 2019 that the drug matched up to placebo on a composite of major cardiac events among nondialysis-dependent patients in a pooled safety analysis. It was comparable to Amgen and Johnson & Johnson's Epogen/Procrit in dialysis-dependent patients and was superior in the incident dialysis subpopulation.
But FibroGen dropped a bombshell in April 2021. Turns out, the safety analyses had been doctored based on several post-hoc adjustments that eventually made roxa look better than it would have under predefined clinical trial terms. The original, unmanipulated data effectively wiped out all the heart safety advantages for roxa that FibroGen had previously touted.
FibroGen's stock price plummeted 43% at the news on April 7. At that time, Conterno said the leadership team only found out about the discrepancy in data reporting while preparing for an FDA advisory committee meeting.
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Things took a turn for the worse in July when the FDA published its internal review of roxa ahead of the meeting. The FDA document highlighted several concerning heart safety signals that were previously unknown to investors, including increased risks of blood clotting and death. Thanks to those problems, the FDA snubbed roxa in August, following an overwhelmingly negative opinion from the advisory committee.
FibroGen’s problematic presentation of roxa’s heart safety data has already drawn multiple lawsuits. Angry investors who lost money after FibroGen’s damaging disclosure have argued that the company breached securities laws by making misleading statements on roxa’s profile and regulatory potential.
Meanwhile, after the FDA rejection, FibroGen and AZ are still working with the FDA to determine a path forward for roxa in the U.S., Conterno said on Monday’s call. The drug has been approved in China and Europe under the brand name Evrenzo.