FDA Clinical Inspection Summary: Adlyxin (lixisenatide) by Sanofi

FDA did not post any warning letters to Sponsors/Monitors/CROs, IRBs or Clinical Investigators this week.  From the archives, here is the Clinical Inspection Summary for Lixisenatide by Sanofi. Sites were selected based on enrollment, receiving speaking fees from the sponsor, larger than average discontinuation rates, higher adverse event rates, high treatment effect and outliers with regards to percent of screened subjects enrolled (100% or low numbers of screened patients enrolled). 

Five sites were inspected. Inspections ranged from one to eleven days. One site received a FDA Form 483. 

Dr. Min was cited for failure to maintain adequate and accurate case histories, specifically:

  • Multiple discrepancies between the CRF and subject diaries for five subjects with regards to dosing of investigational product.