Case Study: Aventis Pharmaceuticals, Inc. achieves FDA-recognized improved physical function claim for Arava® with Optum360 health surveys

Aventis Pharmaceuticals, Inc. - Customer Case Study

Aventis Pharmaceuticals, Inc. needed to prove that its rheumatoid arthritis drug Arava® improves patients’ physical function, but its 1998 NDA contained only one year of data while FDA guidance favored two years and validated outcome measures. To quantify patient-reported benefits Aventis relied on validated instruments including the SF-36 health survey (developed by QualityMetric, now part of Optum360) and the Health Assessment Questionnaire (HAQ).

Using Optum360’s SF-36 data alongside HAQ results, Aventis submitted a supplemental NDA with two‑year clinical outcomes; the FDA accepted the patient‑reported outcome evidence, granted Arava an indication for improved physical function, and established a precedent allowing future approvals based on 12 months of validated PRO data. The studies showed statistically significant improvement at six and 12 months that was maintained at 24 months in patients continuing Arava, delivering a measurable regulatory and marketing impact supported by Optum360’s survey measures.

Aventis Pharmaceuticals, Inc.

Karen Simpson

Arava Medical Product Leader