Ground-Breaking AD Treatment Gains Accelerated FDA Approval

Developing drugs that effectively slow Alzheimer's Disease (AD) progression and conducting successful trials has proven exceptionally challenging for sponsors. AD, a complex neurological ailment, presents numerous hurdles for sponsors. These encompass identifying accurate endpoints for analysis, precise patient diagnosis, and effective management of drug side effects. To furnish requisite safety and efficacy data to regulators, substantial, finely-tuned, and standardized MRI, PET, and ECG data from a broad patient base are imperative. To surmount these obstacles, selecting a provider with profound neuroscience proficiency, extensive data collection and analysis capacities, and global deployment acumen becomes indispensable.

Recently, a ground-breaking AD treatment was accelerated by FDA approval. Over the course of a decade, the large pharmaceutical sponsor responsible for the evaluation of AD treatment had been conducting Phase I to III trials in 15 countries across North America, Europe, and APAC. Read this case study to discover how the large pharma was able to obtain robust and standardized imaging and cardiac safety data for its FDA submission.