Sanofi gives up on amlitelimab in atopic dermatitis
Joe Pee
Sanofi has retreated from a plan to file its anti-OX40L antibody amlitelimab for approval as a treatment for atopic dermatitis (AD) and will abandon development of the drug in this indication.
The decision, announced this morning, comes despite Sanofi's assertions earlier this year that it planned to file amlitelimab in AD on the strength of the phase 3 SHORE and COAST studies.
That came despite some mixed clinical data, and an efficacy signal that some analysts said was unlikely to differentiate the drug from Sanofi's Regeneron-partnered AD blockbuster Dupixent (dupilumab), an IL-4 and IL-13 inhibitor that made nearly $18 billion in global sales last year.
In a statement, Sanofi said that the decision not to submit amlitelimab for approval "was made as part of an ongoing strategic assessment of the pipeline."
Amlitelimab's demise in AD has come despite additional results for the drug from a phase 3 long-term extension study, ESTUARY, which showed long-term maintenance of clinical response without relapse in patients aged 12 years and older with moderate-to-severe AD.
The company now says that the "totality of efficacy and safety evidence" generated for amlitelimab to date suggests there is no point continuing to develop the drug in AD, despite a clear dosing advantage over Dupixent, with four injections a year versus every two to four weeks.
The antibody remains in a phase 2 trial in coeliac disease, with results due in the latter half of this year, but the asset is now much diminished from the 'pipeline-in-a-product' that Sanofi was talking about just a year or two ago.
The decision leaves Sanofi more reliant on two other pipeline projects – anti-CD40L antibody frexalimab and orally-active TNF blocker SAR441566 – as it prepares for the potential loss of patent protection for Dupixent in the early 2030s.
"Patients and their physicians need additional effective treatments due to the heterogeneity of underlying immune mechanisms that contribute to AD, and Sanofi remains committed to pursuing advances in inflammatory skin conditions," said the company, which is not amending its full-year 2026 guidance in light of the move.
"Sanofi will work closely with investigators, site teams, and regulatory authorities to ensure a wind-down of ongoing amlitelimab AD studies, with appropriate transition of care for all enrolled patients."
