BrightInsight’s Patient App, developed in collaboration with Sanofi and Regeneron, has already been adopted by over 25,000 patients using one of Sanofi’s key self-injected biologics. Real-world data from more than 6,000 app users across multiple indications show a 4% reduction in discontinuation rates after one year compared with non-users, as well as a statistically significant improvement in adherence metrics. These results address longstanding industry challenges—World Health Organization studies cite adherence rates as low as 50% for home-administered therapies—by combining drug-specific support features with a user-friendly interface. Based on patient feedback and these early outcomes, Sanofi is now expanding the solution into additional international markets and integrating it across its specialty care portfolio.

The FDA issued a complete response letter for Sanofi’s tolebrutinib application targeting non-relapsing secondary progressive multiple sclerosis, citing six cases that met Hy’s Law criteria for severe drug-induced liver injury—one of which resulted in liver transplantation. The agency concluded that the benefit-risk profile could not be established in any patient subpopulation, pointing to both safety signals and efficacy shortfalls in the Phase 3 dataset. Sanofi has been asked to provide additional safety monitoring data and to conduct further analyses to characterize the risk of liver injury before the application can be reconsidered.

Sanofi is committing $30 million to Enable Injections to accelerate production of the enFuse® On-Body Delivery System (OBDS), strengthen supply-chain capabilities and support global commercial roll-out. The funding will underwrite the build-out of a dedicated manufacturing facility in Ohio and enhance capacity for large-volume subcutaneous injectors, including those used in Sanofi’s Sarclisa® subcutaneous formulation. This follows Sanofi’s participation in Enable’s 2018 $50 million Series B and the 2022 $215 million Series C financing, underscoring a multi-year partnership aimed at improving patient convenience and broadening adoption of wearable delivery technologies.