Eli Lilly submits biologics license application to FDA for lebrikizumab
Eli Lilly and Company has submitted its biologics license application to the FDA for lebrikizumab, a treatment for moderate to severe atopic dermatitis, according to the company’s quarterly earnings report.
The biologics license application submission is supported by results from three phase 3 trials that evaluated the efficacy and safety of lebrikizumab as a monotherapy and in combination with standard-of-care topical corticosteroids in adults and adolescents aged 12 years and older.
“Based on the data we have collected across 2,000 clinical trial patients, we believe lebrikizumab could become a first-line biologic treatment and may offer less frequent dosing for the treatment of moderate to severe atopic dermatitis, a disease where there is significant unmet need for therapies that maintain long-term results,” Ashley Diaz-Granados, senior vice president of U.S. immunology at Eli Lilly and Company, told Healio.
AD is an interleukin-13 (IL-13) dominant disease where IL-13 creates skin barrier dysfunction resulting in itch, skin thickening and risk of infection. Lebrikizumab is an investigational IL-13 inhibitor, designed to bind IL-13 with high affinity, slow disassociation rate and high potency.
“Millions of people are living with autoimmune diseases all over the world, many of which are dermatologic disorders,” Diaz-Granados said. “We look forward to the FDA’s review of the submission and potentially bringing to market an important medicine for people with atopic dermatitis and the physicians who treat them.”
References:
- Lebrikizumab dosed every four weeks maintained durable skin clearance in Lilly's phase 3 monotherapy atopic dermatitis trials. http://lilly.mediaroom.com/2022-09-08-Lebrikizumab-Dosed-Every-Four-Weeks-Maintained-Durable-Skin-Clearance-in-Lillys-Phase-3-Monotherapy-Atopic-Dermatitis-Trials. Posted Sept. 8, 2022. Accessed Nov. 4, 2022.
- Lilly's Lebrikizumab combined with topical corticosteroids showed significant improvements in disease severity for atopic dermatitis. https://investor.lilly.com/news-releases/news-release-details/lillys-lebrikizumab-combined-topical-corticosteroids-showed. Posted April 11, 2022. Accessed Nov. 4, 2022.