European Medicines Agency recommends Adtralza for adolescents with atopic dermatitis

The European Medicines Agency has recommended extending the use of Adtralza in the European Union to adolescents with moderate to severe atopic dermatitis, according to a LEO Pharma press release.

The recommendation from the agency’s Committee for Medicinal Products for Human Use (CHMP) is specifically for adolescents aged 12 to 17 years with moderate to severe atopic dermatitis who are candidates for systemic therapy.

Adtralza (tralokinumab), a high-affinity human monoclonal antibody, is currently approved for adults with moderate to severe atopic dermatitis in the European Union (EU), Great Britain, Canada, United Arab Emirates and Switzerland, as well as in the United States under the trade name Adbry.

“Today’s CHMP opinion underscores our confidence in the safety profile and effectiveness of Adtralza as we seek to obtain regulatory approval to expand its indication for use in an adolescent patient population,” Christophe Bourdon, MBA, CEO of LEO Pharma A/S, said in the release. “There are limited treatment options for adolescents in the EU living with moderate to severe atopic dermatitis. Through our clinical efforts, we have worked to ensure there is sufficient data to support bringing a new biologic option to market for these patients.”

Approval was based on data from a phase 3 ECZTRA 6 trial in which adolescents with moderate to severe AD who were candidates for systemic therapy received a 150 mg or 300 mg dose of Adtralza or placebo every 2 weeks for an initial 16 weeks.

In the treatment group, a significantly greater proportion of patients receiving the Adtralza achieved a 75% improvement in EASI from baseline compared with placebo at week 16.

Pending the European Commission’s final decision, the market authorization will be valid in all EU member states, Iceland, Norway and Liechtenstein if approved. The FDA is also assessing a regulatory filing underway in the United States.