A supplemental Biologics License Application has been accepted by the FDA for treating adolescents and adults with chronic spontaneous urticaria.
The FDA has accepted a supplemental Biologics License Application (sBLA) for dupilumab (Dupixent; Sanofi and Regeneron) for treating chronic spontaneous urticaria (CSU) in patients aged 12 years and older, with the FDA decision target action date set for October 22, 2023.
CSU is an inflammatory skin condition presenting through sudden swelling and hives on the skin, caused partly by type 2 inflammation. Swelling is most common on the face, hands, and feet, but may also occur in the throat and upper airways. H1 antihistamines are commonly used to treat CS by targeting histamine-1 receptors and controlling urticaria symptoms.
Up to 50% of patients with CSU are unable to control the condition with H1 antihistamines and are left to use limited alternative treatment options. Symptoms such as itch or burning persist in these individuals, and often have a significant impact on quality of life.
Dupilumab inhibits signaling in the interleukin (IL)-4 and IL-13 pathways, leading to a decrease in type 2 inflammation. Data from phase 3 trials showed the IL-4 and IL-13 pathways are key drivers in type 2 inflammation, often playing a large role in related and comorbid diseases.
Dupilumab was tested in 2 phase 3 trials, LIBERTY-CUPID Studies A and B. The randomized, double-blind, placebo-controlledtrials analyzed the safety and efficacy of dupilumab in patients with uncontrolled CSU.
In study A, dupilumab was tested as add-on therapy to H1 antihistamines in patients still symptomatic afterantihistamine use not treated with omalizumab. Study B tested dupilumab in patients unresponsive to standard care and omalizumab.
Positive safety and efficacy data was found in both trials, supporting the sBLA submission. Dupilumab has been approved for asthma, atopic dermatitis, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, and prurigo nodularis. Over 500,000 patients worldwide have been treated with dupilumab.
Press Release: Dupixent (dupilumab) application for treatment of chronic spontaneous urticaria (CSU) in adults and adolescents accepted for FDA review. BioSpace. March 7, 2023. Accessed March 7, 2023.