LEO Pharma receives positive CHMP opinion for dermatitis treatment
pharmafile | April 26, 2021 | News story | Sales and Marketing | CHMP, EMA, EU, dermatitis
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting a marketing authorisation of Leo Pharma’s Adtralza (tralokinumab) for the treatment of moderate-to-severe atopic dermatitis in adult patients who are candidates for systemic therapy.
The CHMP positive opinion is one of the final steps before the European Commission makes its decision on the Marketing Authorisation Application for use of Adtralza throughout the European Union.
The final decision is expected in the coming months and if authorised, Adtralza will be the first fully human, monoclonal antibody available to specifically target the IL-13 cytokine, a key driver of atopic dermatitis signs and symptoms.
Jörg Möller, Executive Vice President, Global Research and Development at LEO Pharma, said: “Atopic dermatitis is characterised by its unpredictability, which can be challenging for patients who often experience physical discomfort and emotional effects that may continue for decades.
“Today’s CHMP opinion brings LEO Pharma one step closer to the potential of providing Adtralza as a new therapeutic option for EU patients living with moderate-to-severe atopic dermatitis.”
The CHMP opinion is based primarily on data from three pivotal randomised, double-blind, placebo-controlled trials, which evaluated the safety and efficacy of Adtralza as a monotherapy and with concomitant topical corticosteroids in more than 1,900 adult patients with moderate-to-severe atopic dermatitis.
Primary endpoints for the study were the Investigator Global Assessment score of clear or almost clear skin (IGA 0/1) and at least a 75% improvement in the Eczema Area and Severity Index score.
Pending the final decision from the European Commission, the marketing authorisation will be valid in all European Union member states and Iceland, Norway, and Liechtenstein. Additional regulatory filings are underway with the FDA and other health authorities worldwide.
Kat Jenkins
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