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Houman Ashrafian

Houman Ashrafian

Executive Vice President, Head of Research & Development, Sanofi

Appears in 1 story

Notable Quotes

We are very disappointed by the FDA's action. Disability progression remains a large unmet medical need in MS, and tolebrutinib was awarded breakthrough therapy designation in recognition of its potential to address this critical gap.

Today's FDA decision is a significant and meaningful change in direction from the feedback the agency previously provided to Sanofi. We are very disappointed by the FDA's action. Disability progression remains a large unmet medical need in MS, and tolebrutinib was awarded breakthrough therapy designation in recognition of its potential to address this critical gap.

Stories

The BTK inhibitor race for multiple sclerosis

New Capabilities

Leading Sanofi's response to FDA rejection

The FDA just rejected Sanofi's tolebrutinib for progressive multiple sclerosis on December 28, 2025—a crushing blow for a drug that had won Breakthrough Therapy status and became the first BTK inhibitor approved anywhere in the world. Meanwhile, Roche's rival drug fenebrutinib is racing toward approval after stunning Phase 3 victories, and Merck's evobrutinib crashed out entirely. Three pharma giants bet billions that brain-penetrating BTK inhibitors could finally slow the relentless neurodegeneration that leaves MS patients in wheelchairs. Only one looks likely to reach the finish line first.

Updated Dec 28, 2025