Sanofi abandons plan to seek approval for eczema drug from $1.1B Kymab buyout

Biotech Sanofi abandons plan to seek approval for eczema drug from $1.1B Kymab buyout By James Waldron Jul 24, 2026 5:13am Sanofi atopic dermatitis eczema failed trials Sanofi has abandoned plans to seek approval for amlitelimab in atopic dermatitis (AD), admitting that a drug once tipped as a potential blockbuster “would not represent a meaningful improvement” to existing treatments. Sanofi secured amlitelimab as part of its $1.1 billion acquisition of Kymab back in 2021. But the writing was already on the wall for the anti-OX40 ligand antibody as far back as September 2025, when a phase 3 trial fell short of analyst expectations—and the bar set by Sanofi and Regeneron’s Dupixent—despite hitting the study’s key endpoints. Worse news was to come in January when another phase 3 study recorded a primary endpoint hit but missed on other key measures. Despite the setback, Sanofi committed to seeking approvals “based on the totality of data.” But not long after, Paul Hudson was ousted as Sanofi CEO—in part due to a series of clinical setbacks that included amlitelimab—with R&D chief Houman Ashrafian, Ph.D., later set to follow him out. Hudson’s replacement Belén Garijo has been charged by Sanofi’s board with sorting out the pharma’s R&D strategy and has already made her mark by appointing former Roche executive Paulo Fontoura, M.D., Ph.D., to take over from Ashrafian. It’s under Garijo’s oversight that Sanofi announced this morning that the decision to call time on amlitelimab in AD has been “made as part of an ongoing strategic assessment of the pipeline.” “Sanofi has determined that the totality of efficacy and safety evidence generated to date does not support further development of amlitelimab in AD,” the company explained. “While the Estuary phase 3 long-term extension study showed long-term maintenance of clinical response without relapse in patients aged 12 years and older with moderate-to-severe AD and an emerging safety profile that builds on previous data, amlitelimab would not represent a meaningful improvement to the standard of care for patients with AD,” Sanofi added. Until recently, the official plan had been to seek approval for amlitelimab for AD in the second half of this year. The company had previously decided not to pursue the drug for asthma in the wake of a phase 2 fail last year, although a mid-stage study in celiac disease is set to read out later in 2026. The Paris-based pharma, which is due to report its second-quarter earnings next week, said this morning’s decision does not require the company to amend its full-year 2026 guidance. Sanofi atopic dermatitis eczema failed trials Biotech