EU clears Dupixent as first targeted CSU therapy in over a decade | iPharmaCenter
- ipharmaservices
- 3 days ago
- 3 min read
Dupixent (dupilumab) has been approved in the European Union as the first targeted therapy in more than a decade for chronic spontaneous urticaria (CSU) in patients 12 years and older whose disease remains uncontrolled on standard antihistamines and who are naïve to anti‑IgE therapy.
This decision offers a new first‑line biologic option for an estimated 270,000 adolescents and adults in the EU with CSU inadequately controlled by H1 antihistamines.
EU Dupixent approval overview
The European Commission has authorized Dupixent for moderate‑to‑severe CSU in adults and adolescents aged 12 years and above with an inadequate response to histamine‑1 antihistamines and no prior exposure to anti‑IgE therapy for CSU. Eligible patients can now receive Dupixent as a first‑line targeted biologic, adding CSU to the medicine’s growing list of approved chronic inflammatory indications in the EU.
Dupixent efficacy in CSU: LIBERTY‑CUPID Phase 3 data
The CSU approval is supported by the LIBERTY‑CUPID Phase 3 program, which includes three randomized, double‑blind, placebo‑controlled trials: Studies A, B and C. Studies A and C enrolled 284 patients aged 12 years and older who remained symptomatic despite antihistamines and were naïve to anti‑IgE therapy, while Study B included 108 patients with inadequate response or intolerance to prior anti‑IgE treatment.
Across Studies A and C, Dupixent was evaluated as an add‑on to standard‑of‑care antihistamines versus antihistamines alone and led to significant reductions in overall urticaria activity (a composite of itch and hives), as well as in individual itch and hive severity scores at week 24. More patients receiving Dupixent achieved well‑controlled disease and complete response compared with those on placebo plus antihistamines, and safety findings across all three trials were generally consistent with the known safety profile of Dupixent in its other indications.
Chronic Spontaneous Urticaria: Disease burden and unmet need
CSU is a chronic inflammatory skin disease driven in part by type 2 inflammation, characterized by recurrent hives and intense itch that can be sudden, persistent and debilitating. Standard treatment relies on H1 antihistamines targeting H1 receptors to control urticaria and pruritus, yet many patients continue to have uncontrolled disease even on optimized antihistamine regimens and face few alternative options.
In the EU, more than 270,000 adults and adolescents aged 12 years and older are estimated to have CSU that remains inadequately controlled by antihistamines, with significant impacts on sleep, daily functioning and overall quality of life. The availability of a targeted biologic such as Dupixent is expected to address an important gap in care for this population.
Chronic spontaneous urticaria: Treatment of CSU and Dupixent dosing
For adults with CSU whose symptoms persist despite treatment with H1 antihistamines, Dupixent is administered as a subcutaneous injection, starting with a 600 mg loading dose (two 300 mg injections) followed by 300 mg every two weeks. In adolescents aged 12 to 17 years with CSU inadequately controlled by H1 antihistamines, dosing is weight‑based: those weighing 30 kg to less than 60 kg receive a 400 mg loading dose followed by 200 mg every two weeks, while those weighing 60 kg or more receive a 600 mg loading dose followed by 300 mg every two weeks.
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Dupixent is given under the guidance of a healthcare professional and can be administered in a clinical setting or at home after appropriate training in injection technique.
In adolescents, injections should be administered under the supervision of an adult, and decisions on treatment should take into account disease severity, prior therapies, and the overall benefit–risk profile for each patient.
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