LEO Pharma Inc. Announces U.S. FDA approval of Adbry® (tralokinumab-ldrm) for the Treatment of Moderate-to-severe Atopic Dermatitis in Pediatric Patients Aged 12-17 Years
This critical patient group now has access to a much-needed additional treatment option to manage their atopic dermatitis," said Brian Hilberdink, EVP and President, Region North America, LEO Pharma, “We are delighted to be able to offer Adbry, a highly targeted treatment, to both adult and pediatric patients in the U.S.
- This critical patient group now has access to a much-needed additional treatment option to manage their atopic dermatitis," said Brian Hilberdink, EVP and President, Region North America, LEO Pharma, “We are delighted to be able to offer Adbry, a highly targeted treatment, to both adult and pediatric patients in the U.S.
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The approval is based on data from the Phase 3 ECZTRA 6 trial, which evaluated the efficacy and safety of Adbry in 289 pediatric patients aged 12-17 years with moderate-to-severe AD who were candidates for systemic therapy. - A total of 98 patients received an initial dose of Adbry 300 mg followed by 150 mg every other week up to Week 16.
- “Such advances in the atopic dermatitis treatment landscape provide much-needed hope for pediatric patients seeking a long-term treatment option that could work for them.”
Dr. Paller is an ECZTRA 6 clinical trial investigator and a paid consultant of LEO Pharma Inc.