Sanofi Faces FDA Delay for Tolebrutinib, Simultaneously Announces $2.2 Billion Vaccine Agreement

Paris, France – Sanofi, a leading European pharmaceutical company, is currently navigating a complex landscape of regulatory challenges and significant business developments. The company recently announced a delay in the U.S. Food and Drug Administration (FDA) decision regarding its investigational drug tolebrutinib for non-relapsing secondary progressive multiple sclerosis (nrSPMS), while simultaneously securing a substantial $2.2 billion vaccine deal.

Tolebrutinib Regulatory Review Extended

Sanofi anticipates that the FDA review process for tolebrutinib in nrSPMS will extend beyond the previously communicated target action date of December 28, 2025. The company now expects further guidance from the FDA by the end of the first quarter of 2026. This delay follows a request from the FDA for an expanded access protocol, which Sanofi has submitted, demonstrating its commitment to providing access to the investigational therapy for eligible patients. Sanofi maintains confidence in the drug’s risk-benefit profile for treating nrSPMS.

Multiple sclerosis (MS) is a progressive neurological disorder characterized by the accumulation of disability. Secondary progressive multiple sclerosis specifically affects individuals previously diagnosed with relapsing MS who no longer experience relapses but continue to experience disability progression. Addressing disability accumulation remains a significant unmet require in MS treatment.

Tolebrutinib is an oral, brain-penetrant Bruton’s tyrosine kinase inhibitor designed to target smoldering neuroinflammation, a key driver of disability progression in MS.

$2.2 Billion Vaccine Deal Announced

Concurrent with the FDA update, Sanofi announced a $2.2 billion vaccine deal. Details of the deal were reported shortly after the FDA’s surprising rejection of tolebrutinib.

Sanofi’s Pipeline and Global Presence

As of January 29, 2026, Sanofi’s research and development pipeline includes 80 clinical-stage projects, with 34 in phase 3 or submitted for regulatory approval. These projects span various therapeutic areas, including multiple sclerosis, neurological diseases, inflammatory diseases, autoimmune diseases, rare diseases, and cancer. The company’s product portfolio includes pharmaceutical products (81.8%) and human vaccines (18.2%).

Sanofi operates 37 production facilities worldwide and generates net sales across several key regions: France (3.9%), Europe (17.1%), the United States (50.8%), China (6%), and other regions (22.2%).

Focus on Multiple Sclerosis Research

Sanofi is actively engaged in research and development related to multiple sclerosis, recognizing the need for new solutions in the MS market. The company’s efforts focus on understanding the biology of MS and addressing disability accumulation. Sanofi is investigating B-cell–depleting anti-CD20 therapies and exploring the impact of independent progression versus relapse-associated worsening in MS.