| Drug Name |
EBGLYSS™ (lebrikizumab-lbkz) |
| Active Ingredient |
lebrikizumab |
| Date of Approval |
September 13, 2024 |
| Manufacturer |
Eli Lilly and Company |
| Approval Pathways and Indications |
Approval Pathway: NDA
Indication: EBGLYSS™ is indicated for the treatment of adult and pediatric patients 12 years of age and older who weigh at least 40 kg with moderate-to-severe atopic dermatitis. |
| Therapeutic Class |
Monoclonal Antibody; interleukin-13(IL-13) antagonist |
| Formulation |
Injection: 250 mg/2 mL in a single-dose prefilled pen and prefilled syringe with needle shield |
| MoA |
Lebrikizumab-lbkz is an IgG4 monoclonal antibody that targets IL-13, a cytokine involved in Type 2 inflammation, which plays a key role in atopic dermatitis. By binding to IL-13, it blocks IL-13 signaling through the IL-4Rα/IL-13Rα1 receptor complex, inhibiting the release of proinflammatory cytokines, chemokines, and IgE. However, lebrikizumab-lbkz allows IL-13 to bind to IL-13Rα2, facilitating its natural clearance from the body. |
| Dosing and Administration |
The recommended dosing regimen for EBGLYSS™ is to begin with an initial dose of 500 mg, administered as two 250 mg injections at Week 0 and Week 2. Afterward, continue with 250 mg every 2 weeks until Week 16 or until a sufficient clinical response is achieved. Once the desired response is observed, the maintenance dose is 250 mg every 4 weeks.
All injections should be administered by subcutaneous route.
Sites for injection include the abdomen, thigh, and back of the upper arm. Administration of EBGLYSS in the back of the upper arm may be performed by a caregiver or healthcare provider. The injection site should be alternated with each injection. EBGLYSS should not be injected within 2 inches (5 cm) of the navel or into areas where the skin is tender, bruised, red, hard, or in an area of skin that is affected by atopic dermatitis or skin lesions. |
| Administered by self or by HCP |
Intended for use under the guidance of a healthcare professional. Adult patients may self-inject, or caregivers may give EBGLYSS after training in subcutaneous injection technique. For pediatric patients, caregivers may give injections after training in subcutaneous injection technique. |
| Place in Therapy |
Eczema can affect people of all skin tones, ethnicities, genders and ages with nearly 16.5 million adults in the U.S. having eczema, with 6.6 million experiencing moderate-to-severe symptoms. Patients still struggle to control their moderate-to-severe atopic dermatitis with currently available therapies. Many experience poor long-term disease control.
EBGLYSS™ provides a new first-line biologic treatment for moderate-to-severe atopic dermatitis that is not well controlled with topicals. Patients treated with EBGLYSS™ experienced significant skin clearance as early as four weeks and meaningful itch relief as early as two weeks. EBGLYSS™ delivers long-lasting efficacy for patients through one year of treatment with a monthly maintenance dose.
EBGLYSS™ can be used with or without topical corticosteroids. It is not known if EBGLYSS™ is safe and effective in children less than 12 years of age or in children 12 years to less than 18 years of age who weigh less than 88 pounds (40 kg). Patients should avoid receiving any live vaccines if they are being treated with EBGLYSS™. |
| Expected Market Launch Date |
4th quarter of 2024 |
| New Molecular Entity (NME) or Existing Formulation |
New Molecular Entity |
| Expected Cost |
Data Unavailable |
| Product Discontinuation |
N/A |
| Clinical Trials |
The clinical trials for EBGLYSS™ involved three key studies, ADvocate 1, ADvocate 2, and ADhere, which evaluated its efficacy in treating moderate-to-severe atopic dermatitis in patients whose condition was not adequately controlled by topical medications. These were multicenter, randomized, double-blind, placebo-controlled trials. ADvocate 1 and ADvocate 2 focused on EBGLYSS™ as a monotherapy, while ADhere studied EBGLYSS™ in combination with topical corticosteroids. A total of 1,062 participants aged 12 years and older were enrolled, with disease severity characterized by an Investigator's Global Assessment (IGA) score of 3 or higher, an Eczema Area and Severity Index (EASI) score of 16 or more, and a body surface area involvement of at least 10%.
The primary outcome measure for these trials was the proportion of patients who achieved an IGA score of 0 (clear) or 1 (almost clear), along with at least a two-point improvement from baseline at Week 16. Secondary endpoints included the proportion of patients who achieved a 75% reduction in EASI (EASI-75), a 90% reduction in EASI (EASI-90), and an improvement in itch severity, as defined by a reduction of four or more points on the Pruritus Numeric Rating Scale (NRS).
The results from ADvocate 1 and ADvocate 2 showed that 43% and 33% of patients treated with EBGLYSS™, respectively, achieved an IGA score of 0 or 1 by Week 16, compared to 13% and 11% in the placebo groups. In terms of EASI-75, 59% of patients in ADvocate 1 and 52% in ADvocate 2 reached this benchmark, compared to just 16% and 18% of placebo patients. EASI-90 results showed that 38% and 31% of EBGLYSS™ treated patients achieved a 90% reduction in symptoms, compared to 9% and 10% in the placebo groups. Additionally, 46% of patients in ADvocate 1 and 40% in ADvocate 2 reported a significant reduction in itch severity, compared to only 13% and 12% in the placebo groups.
Long-term maintenance data further demonstrated the sustained efficacy of EBGLYSS™. Among patients who responded by Week 16, 65-76%, and 74-81% of patients receiving EBGLYSS™ every two or four weeks, respectively, maintained an IGA 0 or 1 score through Week 52, indicating that the benefits of the treatment were durable over time. |
| Sources |
Drugs.com. Ebglyss. https://www.drugs.com/history/ebglyss.html. Accessed September 16, 2024.
Eli Lilly and Company. FDA approves Lilly's Ebglyss™ (lebrikizumab-lbkz) for adults and adolescents with moderate-to-severe atopic dermatitis. https://investor.lilly.com/news-releases/news-release-details/
fda-approves-lillys-ebglysstm-lebrikizumab-lbkz-adults-and. Accessed September 16, 2024.
Eli Lilly and Company. Ebglyss. https://ebglyss.lilly.com/?gad_source=1&gclid=Cj0KCQjwrp-3BhDgARIsAEWJ6Sx_
CVjA5jj8a-jSpIM8Kp1Ijk7G5dfFePBIk2stcDSg3KPLIzLPSQUaAsDeEALw_wcB.
Accessed September 16, 2024.
Eli Lilly and Company. Ebglyss (lebrikizumab-lbkz) Prescribing Information. https://pi.lilly.com/us/ebglyss-uspi.pdf. Accessed September 16, 2024. |