Sanofi has secured priority review from the US Food and Drug Administration (FDA) for its human monoclonal antibody Dupixent (dupilumab) as an add-on maintenance treatment for severe chronic rhinosinusitis with nasal polyps (CRSwNP).
The priority review for Dupixent is for the treatment of adult patients whose CRSwNP is inadequately controlled.
CRSwNP is a chronic disease of the upper airway. It is primarily caused by type 2 inflammation and is characterized by abnormal tissue growths that block the sinuses and nasal passages. People having both co-morbid asthma and CRSwNP are prone to have more severe disease and are often tough to treat.
According to Sanofi, patients with severe CRSwNP regularly experience recurrence of the disease in spite of previous treatment through surgery and/or systemic corticosteroids. Nearly 60% of patients in the late-stage trials had co-morbid asthma, said the French pharma company.
The FDA is expected to take a decision on the approval of the Sanofi drug in late June 2019.
The supplemental Biologics License Application (sBLA) for the drug covers data from two phase 3 trials, which assessed its efficacy and safety in combination with standard-of-care corticosteroid nasal spray. The trials were held in patients with recurring severe CRSwNP despite their previous treatment, which involved either surgery and/or systemic corticosteroids.
Sanofi, in a statement, said: “Dupixent is a targeted biologic therapy that inhibits signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13), two key proteins that may play a central role in type 2 inflammation, which seem to underlie CRSwNP as well as several other allergic diseases.”
The drug is approved in the US for the treatment of moderate-to-severe atopic dermatitis (eczema) in adults. It is also indicated for use as maintenance treatment along with other asthma medicines of moderate-to-severe asthma in people aged 12 years and older.
In the European Union (EU), Canada and Japan, Dupixent is approved for the treatment of moderate-to-severe atopic dermatitis in certain adult patients.
Earlier this month, the drug was recommended by the Committee for Medicinal Products for Human Use (CHMP) for an approval by the European Medicines Agency (EMA) as an add-on maintenance treatment for severe asthma with type 2 inflammation in both adults and adolescents.