LEO Pharma's Tralokinumab-ldrm Bags US FDA Nod To treat Atopic Dermatitis

As per LEO Pharma Inc, Adbry (tralokinumab-ldrm) is now approved for use in pediatric patients with moderate-to-severe atopic dermatitis (AD) aged 12 to 17 years. This approval extends to patients whose disease is not adequately controlled with topical prescription therapies or when those therapies are not recommended, 

Adbry is the first and only US FDA-approved biologic that specifically binds to and inhibits the interleukin (IL)-13 cytokine, one of the key drivers of AD signs and symptoms, as per pharma biz.

"This is an important milestone on our path towards making a fundamental difference for those who need it most. 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 US. This debilitating disease can have a particularly strong impact on paediatric patients, who often feel socially isolated because of their condition.  We are incredibly proud of the progress we have made to date, and we will continue to work hard to address unmet needs in additional patient populations."

For US pediatric patients 12 to 17 years old, a loading dosage of 300 mg is authorized to be administered first, and then a 150 mg dose every two weeks after that.

The approval is predicated on information from the phase 3 ECZTRA 6 clinical study, which assessed Adbry's safety and effectiveness in 289 pediatric patients with moderate-to-severe AD who were candidates for systemic therapy and were between the ages of 12 and 17.