Regeneron Pharmaceuticals, Inc. and Sanofi have announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for the treatment of adult and paediatric patients aged 6 years and older with allergic fungal rhinosinusitis (AFRS) who have a history of sino-nasal surgery.
The FDA evaluated Dupixent under Priority Review for the treatment of AFRS, which is reserved for medicines that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions. The approval expands approved indications in sino-nasal diseases to now include AFRS, alongside chronic rhinosinusitis with nasal polyps.
“Allergic fungal rhinosinusitis (AFRS) is a disease that can leave both children and adults with inflamed nasal passages, nasal polyps and thick mucus causing constant nasal congestion. Some patients can also experience more serious complications like deterioration of bone around the sinuses and facial deformities,” said Kenneth Mendez, president and CEO, Asthma and Allergy Foundation of America (AAFA).
“As the first treatment specifically approved for AFRS, Dupixent offers the potential for relief to adults and children six years and older struggling with potentially debilitating symptoms.”
AFRS is a chronic type 2 inflammatory disease. It is a specific subtype of chronic rhinosinusitis distinctly caused by an intense allergic hypersensitivity to fungi. It primarily affects people living in warm, humid climates where fungal spores are common in the environment. It can lead to nasal polyps, nasal congestion, loss of smell, thick mucus discharge, poor health-related quality of life, and patients can also experience bone loss around the sinus cavities and facial deformities.
AFRS can be a severe and hard-to-treat form of chronic rhinosinusitis because it may not respond well to available options. Current standard-of-care treatment is surgery and prolonged courses of systemic steroids; however, disease recurrence is not uncommon.
“With this approval, Dupixent once again demonstrates its value in advancing the treatment landscape for a chronic type 2 inflammatory disease with high unmet need,” said George D. Yancopoulos, board co-chair, [resident and chief scientific officer at Regeneron, and a principal inventor of Dupixent.
“Beyond reducing nasal signs and symptoms, Dupixent reduced the need for surgery or systemic corticosteroids with fewer patients having bone erosion in the sinuses. These results underscore its potential to establish a new standard of care for people living with AFRS. This ninth FDA approval for Dupixent, the most widely used innovative branded antibody medicine, strengthens the established efficacy and body of evidence that IL-4 and IL-13 are major drivers of type 2 inflammation across many chronic diseases.”
“Before Dupixent, people living with allergic fungal rhinosinusitis had to rely on treatments that left them potentially vulnerable to regrowth of nasal polyps and thick mucus that could rob them of their sense of smell,” said Alyssa Johnsen, global therapeutic area head, Immunology Development at Sanofi.
“As the first medicine approved specifically for AFRS, Dupixent has been proven to lessen multiple signs and symptoms of disease, help break the cycle of recurrence, and reduce the risk for subsequent surgeries and corticosteroids by 92%. We look forward to working with regulators in other countries to bring this innovative option to more patients in need.”
Additional submissions are planned to other regulatory authorities around the world.
Regeneron and Sanofi also announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of Dupixent in the European Union for the treatment of chronic spontaneous urticaria (CSU). The recommendation covers children aged 2 to 11 years with moderate-to-severe CSU, an inadequate response to histamine-1 antihistamines (H1AH) and who are naïve to anti-immunoglobulin E (IgE) therapy for CSU. A final decision is expected in the coming months.