LEO Pharma’s Eczema Drug Wins FDA Approval

With 2021 nearly over, LEO Pharma has scored a big victory with Adbry (tralokinumab-ldrm), earning the FDA’s blessing for treating moderate-to-severe eczema (atopic dermatitis). The approval marks the Denmark-based company’s first U.S. biologic.

The injectable monoclonal antibody is now the first and only FDA-approved biologic that specifically attaches to and acts on the IL-13 cytokine, which is known to play a big role in the signs and symptoms of the common skin condition.

The agency’s approval appears to justify LEO Pharma’s $115 million gamble five years ago to buy the exclusive global rights to AstraZeneca’s (AZ) tralokinumab in atopic dermatitis and any other future dermatology indications. At the time, AZ was still evaluating the drug as a severe asthma treatment; the last word on that was in 2017, when it failed two pivotal asthma trials.

Besides the FDA approval, tralokinumab has seen a stellar year, earning regulatory approvals in the EU, UK, Canada and the United Arab Emirates.