FDA hits Acceleron Pharma with notice of noncompliance

FDA has sent its first notice of noncompliance to Acceleron Pharma (NSDQ:XLRN), accusing the company of failing to submit summary results information to ClinicalTrials.gov for a Phase 2 trial.

The agency sent the company a letter warning of potential noncompliance in July 2020.

The National Library of Medicine, a part of the National Institutes of Health, operates the ClinicalTrials.gov database.

The clinical trial in question is an unsuccessful randomized, double-blind study comparing the combination of dalantercept (ACE-041) and axitinib (AG013736) to placebo plus Axitinib in patients with advanced renal cell carcinoma.

“Acceleron is in receipt of a notice of non-compliance from the FDA related to the posting of data on the website clinicaltrials.gov from a Phase 2 clinical trial of the investigational agent dalantercept,” said Matt Fearer, senior director, corporate communications at Acceleron Pharma. After the trial failed to reach its primary endpoint in 2017, Acceleron discontinued development of dalantercept.

The recent notice gives Acceleron 30 days to provide the summary results information FDA requires.

“Acceleron places the utmost importance on meeting its obligations to the FDA and all other regulatory authorities,” Fearer said. “Accordingly, the company will post the trial results on clinicaltrials.gov within the 30-day remediation period set forth by the agency.”

Companies typically have one year after trial completion to post results to the ClinicalTrials.gov site.

FDA has threatened the company with fines if it fails to release results from the trial. Parties can, however, request a delay or a waiver.

Financial penalties for failure to comply with the requirements can be as $10,000 for each day of the violation until the violation is corrected. Failing to comply with the relevant regulations of the FD&C Act can also face injunction or criminal prosecution.