FDA Approves Lilly's EBGLYSS for Ages 12+

Eli Lilly and Company has received FDA approval for EBGLYSS (lebrikizumab-lbkz), a new treatment option for moderate-to-severe atopic dermatitis in adults and children aged 12 and older. This new medication serves as an IL-13 inhibitor specifically aimed at individuals who have not experienced significant relief from topical prescriptions.

EBGLYSS is administered via injection and targets the inflammation associated with eczema. The treatment regimen begins with a 500mg dose at the initial administration and another at the two-week mark. This is followed by a 250mg dose every two weeks until week 16. If the patient shows a satisfactory clinical response, the dosage is then reduced to a single monthly maintenance injection. Notably, EBGLYSS can be used with or without the addition of topical corticosteroids.

The FDA's decision to approve EBGLYSS was influenced by data from three clinical trials: ADvocate 1, ADvocate 2, and ADhere. These trials included over 1,000 adult and pediatric subjects with moderate-to-severe eczema and demonstrated the efficacy of EBGLYSS in achieving clear or near-clear skin after 16 weeks of treatment.

Daniel Skovronsky, President of Lilly Immunology and Chief Scientific Officer of Lilly Research Laboratories, emphasized the significant impact of eczema on patients' lives, noting that symptoms can arise unpredictably and disrupt daily activities. He highlighted that the approval of EBGLYSS offers a targeted approach to treating eczema inflammation, providing long-lasting symptom relief through a convenient once-monthly maintenance dose.

Lilly is gearing up to introduce EBGLYSS to the U.S. market and is collaborating with various stakeholders to ensure patients have access to the medication. Lilly Support Services for EBGLYSS will offer a comprehensive patient support program, which includes co-pay assistance for those eligible.

Following its earlier approvals in the European Union in 2023 and Japan in January 2024, EBGLYSS is also set to expand into additional markets by the end of 2024. While Lilly holds exclusive rights to its global development and commercialization outside of Europe, the company’s partner Almirall is licensed to market the treatment for dermatological conditions, including eczema, within Europe.

In a significant development in July 2024, the National Institute for Health and Care Excellence (NICE) in the United Kingdom recommended EBGLYSS (lebrikizumab) for patients with moderate to severe atopic dermatitis. This endorsement provides National Health Service (NHS) patients with an additional biological therapy option.

Eli Lilly's announcement of EBGLYSS marks a significant milestone in the treatment of atopic dermatitis, offering new hope to patients who have struggled with this chronic condition. The company's forward-thinking approach aims to enhance the quality of life for those affected by eczema, providing an effective and convenient treatment alternative.