Eli Lilly's eczema drug receives FDA approval one year after its initial rejection

The FDA has granted Eli Lilly approval for Ebglyss (lebrikizumab-lbkz) for the treatment of moderate-to-severe atopic dermatitis, also commonly known as eczema. The drug is intended for patients whose condition cannot be controlled well with topical prescription therapies and continue to suffer from inflammation causing dry, itchy and irritated skin.

"Patients still struggle to control their moderate-to-severe atopic dermatitis with currently available therapies. Many experience poor long-term disease control, and severe itch can significantly impact their daily lives," said Jonathan Silverberg, professor of dermatology at George Washington University School of Medicine and Health Sciences. "[The] FDA approval of Ebglyss is a big win for patients, as we now have a new first-line biologic treatment option for moderate-to-severe disease when topical prescriptions aren't enough."

Ebglyss is a monoclonal antibody drug that targets the IL-13 cytokine, a molecule that is involved in the inflammatory process that drives the symptoms of eczema. The approval was supported by data from three clinical trials that together enrolled over 1,000 people with moderate-to-severe eczema who were not able to manage their symptoms with topical prescription medicines.

Results from the clinical studies showed that 38% of people who received Ebglyss had clear or almost-clear skin after 16 weeks of treatment, and 77% of them maintained those results after one year. When it came to itch symptoms, 43% of patients felt itch relief after 16 weeks, and 85% of them still felt that relief after one year. One of the key features of Ebglyss that were confirmed during the trials is that once patients achieve a clinical response, the treatment can be maintained with a single monthly injection.

The FDA initially rejected Eli Lilly’s marketing authorization application for Ebglyss in October 2023. The regulatory agency did not raise concerns about the data from clinical trials, but rather revolved around an inspection of a third-party contract manufacturing organization that produced the active compound of the drug.

At the time, a representative from Eli Lilly stated that the company would work closely with the CRO and the FDA to address the agency’s feedback and make the drug available to patients. Almost one year later, the original concerns of the FDA seem to have been addressed as the agency decided to grant approval to the monoclonal antibody drug. 

The FDA approval comes after Ebglyss was approved in the European Union in 2023 and in Japan in early 2024. Eli Lilly expects the drug to receive approval in additional markets later this year.