The company is currently running 13 Phase III trials for its lead drug masitinib in a number of oncology indications, as well as for other inflammatory and neurodegenerative diseases.
The warning letter cites the company’s failure to appropriately monitor three protocols which resulted in the inability to identify and correct clinical investigators’ failures to report serious adverse events (SAEs) as specified under the protocols. The company was also cited for failing to perform protocol-required lab tests.
The FDA found that in some cases the unidentified site in question didn’t report the SAEs on the appropriate form, while in other instances it took the site years to report the SAEs.
The FDA also took issue with AB Science’s written response from last October to the Form 483 the FDA previously issued, noting it “is inadequate because your proposed corrective actions make no provisions for assessing the effectiveness of and ensuring sustained compliance with your monitoring practices.”
Monitoring reports were also not completed and approved within the timeframes specified in the monitoring guidelines, and in some instances, were not completed at all, the FDA found.
In its defense, AB Science said in a statement that it responded to the deviations with “appropriate corrective and preventive actions,” and that the FDA “did not issue any comment in its letter regarding the relevance of the corrective and preventive actions implemented by AB Science. Rather, the FDA has requested AB Science to detail the activities to: measure the effectiveness of these corrective and preventive actions; [and] ensure the sustained compliance of these corrective and preventive actions.” On both accounts AB Science says it has responded to the FDA.
The company also said it’s been inspected more than a dozen times by “numerous health authorities and always responded satisfactorily.”