Summary
The FDA released it's pre-meeting review online this past Friday, and clearly had some concerns. Acorda will need to address these very thoroughly and seriously.
Analysis
The FDA specifically questioned the robustness of the SPA primary outcome and its clinical significance. Secondary analyses were not demonstrating a very large difference between the treatment and placebo group. They were not impressed with selecting just the responders from the total treated population for the analysis. They also raised issues regarding safety in regards to seizure potential, MS worsening upon discontinuation, and urinary tract infections. Finally, they were also concerned that the proper dose has yet to be established. However, Acorda still has a very good chance of having the medicine approved. The potential options for black box warnings, need for EEGs, additional reported adverse events, and labeling for a specific subset of MS patients is beginning to emerge. Despite the very critical and skeptical report, there is room to address the criticisms and move forward with approval.
This author consults with leading institutions through GLG
Analyses are solely the work of the authors and have not been edited or endorsed by GLG.
