Sanofi’s Plavix Arm Stands Firm as Rivaroxaban Arm Halts in Phase 3 Trial
NIH halted the low-dose rivaroxaban arm in the 1,683-patient Phase 3 CAPTIVA stroke trial after identifying increased safety events and a futility threshold, leaving Sanofi’s 75 mg Plavix arm as the control comparator. Sanofi was omitted from recent federal drug-pricing agreements and is evaluating alternative contracting models to offset revenue pressures.
1. NIH Halts Low-Dose Rivaroxaban Arm
The National Institutes of Health discontinued the low-dose rivaroxaban arm in the Phase 3 CAPTIVA stroke prevention trial after an independent safety review cited increased adverse events and failure to meet a pre-set futility threshold. The decision affects all 1,683 enrolled participants across over 100 sites, and study sites have been instructed to stop rivaroxaban while Sanofi’s clopidogrel (Plavix) arm continues as the comparator.
2. Sanofi Excluded from Federal Drug-Pricing Deals
Sanofi was among several major pharma firms left out of the administration’s recent federal drug-pricing agreements designed to cap prices for top-selling therapies. In response, the company is exploring new contracting approaches, including direct-to-payer agreements and performance-based models, to mitigate potential revenue impacts.