Dupixent Supplemental Application Submitted in Japan for Allergic Fungal Rhinosinusitis – Sanofi
Sanofi K.K. announced that today it submitted an application to Japan’s Ministry of Health, Labour and Welfare for a partial change to the marketing authorization for Dupixent as a treatment for allergic fungal rhinosinusitis (AFRS).
AFRS is a type of chronic rhinosinusitis and is a chronic type 2 inflammatory disease of the sinuses caused by a strong allergic hypersensitivity reaction to fungi, mainly Aspergillus. It tends to be more common among people living in warm and humid regions where fungal spores are abundant in the environment.
The disease causes symptoms including nasal polyps, nasal congestion, impaired sense of smell and thick nasal discharge, and reduces quality of life. In severe cases, it may cause destruction of the bones surrounding the sinuses and facial deformity.
In addition, AFRS may progress to severe and refractory chronic rhinosinusitis when existing treatment options do not provide sufficient efficacy. Recurrence may also occur even after the current standard treatments of surgery and systemic corticosteroid therapy. At present, no biologic has been approved as a treatment for AFRS.
Dupixent is a fully human monoclonal antibody that inhibits the actions of IL-4 and IL-13, proteins that play central roles in type 2 inflammation. Type 2 inflammation has been shown to play an important role in the pathophysiology of AFRS, as it does in the indications for which Dupixent has already been approved.
This application is based on the results of the Phase III LIBERTY-AFRS-AIMS trial (Study ID: NCT04684524).
The trial enrolled a total of 62 adult and pediatric patients aged 6 years and older with AFRS, including Japanese patients. Patients were randomized to receive Dupixent 200 mg or 300 mg once every two weeks or once every four weeks, depending on age and body weight in pediatric patients, in the Dupixent group (n=33), or placebo in the placebo group (n=29).
