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 Taltz (IXEKIZUMAB) from Eli Lilly.
Two studies were submitted in support of the marketing application. Three clinical sites were selected for inspection. One site was selected because it participated in both pivotal trials, but with different results between the two trials. One site was selected because it participated in both trials, had very low efficacy results for the comparator arm, and very low efficacy results for the treatment arm. The third site participated in one of the trials due to low efficacy in all arms of the trial. Inspections ranged over one week to three weeks. Two sites received 483s.
Dr. Blauvelt was cited for:
- Unused investigational product was not disposed according to sponsor instructions
- Case histories were not accurate
- The investigation was not conducted according to plan, specifically:
- Two subjects met exclusion criteria but were entered into the study
- One subject was hospitalized for a hip arthroplasty which was not promptly reported as a Serious Adverse Event (SAE)
- The site used a different form for rating subject illness than the one required by the sponsor. FDA notes that study data was rerun excluding data from Dr. Blauvelt's site to determine if the use of the different form had an impact.
Dr. Birbara was cited for enrolling one subject who was administered an excluded concomitant medication throughout the trial.