LEO Pharma announced that the U.S. FDA has approved human monoclonal antibody Adbry for the treatment of moderate-to-severe atopic dermatitis in adults.
LEO, a Danish medical dermatology specialist, says this makes Adbry the first and only FDA-approved biologic that specifically binds to and inhibits the IL-13 cytokine, a key driver of atopic dermatitis signs and symptoms. The company says the approval is a big milestone for people living with eczema who struggle to find effective control for the chronic disease.
The approval of Adbry — already marketed outside of the U.S. as Adtralza — is based on safety and efficacy results from the ECZTRA 1, 2 and ECZTRA 3 pivotal phase 3 trials, which included nearly 2,000 adult patients with moderate-to-severe atopic dermatitis.
LEO bought the treatment from AstraZeneca for $115 million in 2016. At the time, it was also in phase 3 development for patients with severe asthma, but ultimately failed to meet its primary endpoint in the first of two pivotal phase 3 studies.
The drugmaker plans to launch Adbry in the U.S. in February. It will compete with Regeneron's well-established Dupixent, which got its first FDA approval in 2017. Dupixent, however, is known to have side effects — including conjunctivitis and neck and head dermatitis — while Adbry trials reported less common incidences of adverse events.
