R&D

Sanofi has announced that the US Food and Drug Administration (FDA) has accepted its supplemental biologics licence application (sBLA) for priority review for the treatment of bullous pemphigoid (BP). The sBLA is for Dupixent (dupilumab), which has already received regulatory approvals in more than 60 countries for certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic oesophagitis, prurigo nodularis, chronic spontaneous urticaria,and chronic obstructive pulmonary disease in different age populations.

The sBLA has been granted on the basis of data from clinical study ADEPT, which evaluated its investigational use in 106 adults with moderate-to-severe BP in 2024. This study met the primary and all key secondary endpoints, demonstrating sustained disease remission in five times more patients than those on placebo. It was also previously given orphan drug designation.

Dupilumab is a fully human monoclonal antibody that inhibits the signalling of the interleukin-4(IL4) and interleukin-13 (IL13) pathways and is not an immunosuppressant, which is administered by pre-filled syringe or pen by the patient’s doctor. It is being jointly developed by Sanofi and Regeneron.