Using Real-world Data to Support Product Label Change
Using Real-world Data to Support Product Label Change
Case Study:
Leveraging Real-World Data to Support a Product Label Change
This case study highlights how a mid-size pharmaceutical company used real-world evidence (RWE) to support a supplemental NDA submission for a higher-dosage chemotherapy option in an oncology indication.
Key takeaways include:
- Challenge: Demonstrate the safety and effectiveness of a higher dosage chemotherapy regimen to justify a product label update.
- Approach: Magnolia Market Access conducted a retrospective cohort study, employing advanced methodologies such as inverse probability treatment weighting, Cox proportional hazards models, and Kaplan-Meier survival analysis.
- Outcome: Results supported a conference abstract, poster presentation, and the supplemental NDA submission, leading to the addition of the higher-dosage option on the product label.
Download the case study to explore how real-world data can drive regulatory success and enhance market positioning.
