The MHRA and EC have approved Leo Pharma’s Adtralza (tralokinumab) for adults with moderate-to-severe atopic dermatitis who are candidates for systemic therapy.
The approvals make tralokinumab the first and only approved biologic that specifically targets the IL-13 cytokine alone, a key driver of atopic dermatitis signs and symptoms.
Tralokinumab is the first high affinity, human monoclonal antibody developed to specifically bind to and inhibit the IL-13 cytokine in adult patients with uncontrolled moderate-to-severe atopic dermatitis.
Tralokinumab will be available in a 150 mg/mL prefilled syringe for subcutaneous injection with an initial dose of 600 mg followed by 300 mg every other week.
Tralokinumab can be used with or without topical corticosteroids.
Professor Anthony Bewley, Consultant Dermatologist at Barts Health NHS Trust, said: “Atopic dermatitis can be an intensely itchy, challenging, and unpredictable skin condition for some.
“As clinicians, we always want more options for patients and the approval of tralokinumab means that clinicians across the UK and Ireland now have an important new treatment option for patients with moderate-to-severe atopic dermatitis in adult patients.”
Dr. Amit Aggarwal, Medical Director, LEO Pharma UK and Ireland, said: “The MHRA and EC approval of tralokinumab is a significant milestone for thousands of adults in Europe living with atopic dermatitis.
“Tralokinumab was developed based on the advanced understanding of the immune processes underlying atopic dermatitis, which is fundamental to our mission of pioneering medical dermatology.”
The approval is based primarily on safety and efficacy results Phase III trials, which included more than 1,900 adult patients with moderate-to-severe atopic dermatitis.
Atopic dermatitis is a chronic, inflammatory, skin disease characterized by intense itch and eczematous lesions.
The condition is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.
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