US-based drugmaker Eli Lilly and Company (Lilly) has received the US Food and Drug Administration (FDA) approval for its Ebglyss (lebrikizumab-lbkz) to treat a type of atopic dermatitis (eczema).
Ebglyss is a targeted IL-13 inhibitor that works by targeting eczema inflammation throughout the body that can lead to dry, itchy, and irritated skin.
The drug is indicated for individuals aged 12 years and above, who weigh at least 40kg, with moderate-to-severe eczema that is not well controlled with topical therapies.
Ebglyss 250mg/2 mL injection can be used with or without topical corticosteroids and is dosed as a single monthly maintenance injection following the initial phase of treatment.
Its recommended initial starting dose is 500mg (two 250 mg injections), followed by 250mg every two weeks until Week 16 or later when adequate clinical response is achieved.
A single monthly injection of 250mg every four weeks is recommended as maintenance.
Lilly Research Laboratories chief scientific officer and president, and Lilly Immunology president Daniel Skovronsky said: “People living with eczema have symptoms that can appear at the most inopportune times, creating unpredictability and impacting their everyday lives.
“Today’s approval allows people the opportunity to reimagine life with eczema as EBGLYSS offers a targeted approach to reduce a main cause of eczema inflammation.”
The FDA approval was based on results from the ADvocate 1, ADvocate 2, and ADhere studies.
The studies included more than 1,000 adults and children, aged 12 and above, with moderate-to-severe eczema who were unable to control their symptoms with topical medicines.
The primary endpoint for the clinical studies was clear or almost clear skin at 16 weeks.
In an average of two studies, 38% of people who received Ebglyss achieved clear or almost clear skin at 16 weeks and 10% within four weeks, compared to 12% with a placebo.
A majority of the people who achieved clear or almost clear skin (77%) at Week 16 maintained the results at one year with once-monthly dosing.
Also, 48% of responders who were switched from Ebglyss to placebo at Week 16 maintained these results for one year.
Similarly, many people experienced itch relief with Ebglyss, where an average of 43% of people who took Ebglyss felt itch relief at 16 weeks, compared to 12% with a placebo.
The most common side effects of Ebglyss include eye and eyelid inflammation, such as redness, swelling and itching, injection site reactions and shingles.
Ebglyss is not advised for people allergic to lebrikizumab-lbkz or to any Ebglyss ingredients.
Lilly intends to commercialise Ebglyss in the US in the coming weeks and is working with insurers, health systems and providers to enable patient access to Ebglyss.
The US drugmaker will offer ‘Lilly Support Services for Ebglyss’, a patient support program that includes co-pay assistance for eligible, commercially insured patients.
Ebglyss was approved in the European Union (EU) last year and in Japan this year, with additional markets expected to approve the drug later this year.
Lilly holds exclusive rights to develop and commercialise Ebglyss in the US and the remaining territories outside Europe, where its partner Almirall has licensed the rights in Europe.
