FDA Approves Adbry for Atopic Dermatitis in 12 to 17 Year Olds

The FDA has expanded the approval of Leo Pharma’s Adbry (tralokinumab-ldrm) to include pediatric patients aged 12 to 17 years with moderate-to-severe atopic dermatitis (AD). It’s indicated for patients whose disease is not adequately controlled with topical prescription therapies. Adbry is already approved for patients 12 years of age and older.

Adbry is a biologic that specifically binds to and inhibits the interleukin (IL)-13 cytokine, one of the key drivers of atopic dermatitis signs and symptoms. For the 12- to 17-year-old patient population, the initial dose of 300 mg is followed by a 150 mg dose every two weeks.

The price of Adbry is $1,810.87 for a two-syringe pack; a pack of four syringes has a price of $3,621.73, according to a company spokesperson.

Leo offers several programs, include a $0 copay program for those with commercial insurance, a bridge program for insured patients whose insurance does not yet cover Adbry, as well as a patient assistance program for those without insurance.

Atopic dermatitis is a chronic, inflammatory skin disease characterized by intense itch and lesions. IL-13 has been identified as a key cytokine that plays an important role in atopic dermatitis. There are an estimated 2.4 million patients aged 12 to 17 years of age in the United States living with atopic dermatitis, with about half moderate-to-severe disease.

The approval in the pediatric population is based on data from the phase 3 ECZTRA 6 trial, which evaluated the efficacy and safety of Adbry in 289 patients aged 12 to 17 years of age. In the trial, more than five times as many pediatric patients had clear or almost clear skin with Adbry compared with placebo, and about seven times as many pediatric patients experienced significantly reduced itch with Adbry compared with placebo.

Data from ECZTRA 6 was presented in March 2023 at the American Academy of Dermatology (AAD) 2023 Annual Meeting.