EBGLYSS™ (lebrikizumab-lbkz), a targeted IL-13 inhibitor from Eli Lilly and Company, has received FDA approval for the treatment of adults and children 12 years of age and older who weigh at least 88 pounds (40 kg) with moderate-to-severe atopic dermatitis (eczema) that is not well controlled despite treatment with topical prescription therapies.
EBGLYSS 250mg/2mL injection can be used with or without topical corticosteroids and is dosed as a single monthly maintenance injection following the initial phase of treatment. The recommended initial starting dose of EBGLYSS is 500mg (two 250mg injections) at Week 0 and Week 2, followed by 250mg every two weeks until Week 16 or later when adequate clinical response is achieved; after this, maintenance dosing is a single monthly injection (250mg every four weeks).
Approval is based on results from the ADvocate 1, ADvocate 2, and ADhere studies, which included more than 1,000 adults and children aged 12 and older with moderate-to-severe eczema who were unable to control their symptoms with topical prescription medicines. The primary endpoint for these studies was evaluated at 16 weeks and measured clear or almost clear skin (IGA 0,1).
In an average of two studies (ADvocate 1 and 2), 38% of people who took EBGLYSS achieved clear or almost-clear skin at 16 weeks (versus 12 percent with placebo) and 10% saw these results as early as four weeks. Of the people who experienced clear or almost-clear skin at Week 16, 77%maintained those results at one year with once-monthly dosing. Forty-eight percent of responders who were switched from EBGLYSS to placebo at Week 16 maintained these results at one year.
On average, 43% of people who took EBGLYSS felt itch relief at 16 weeks (compared to 12 percent who took placebo) and 5% felt relief as early as two weeks.
The most common side effects of EBGLYSS include eye and eyelid inflammation, such as redness, swelling and itching; injection site reactions and shingles (herpes zoster). The maintenance period was generally consistent with the 16-week safety profile throughout multiple studies.
Lilly expects EBGLYSS to be available in the United States in the coming weeks. Through Lilly Support Services™ for EBGLYSS™, the company will offer a patient support program including co-pay assistance for eligible, commercially insured patients.
Lilly has exclusive rights for development and commercialization of EBGLYSS in the US and the rest of the world outside Europe. Lilly’s partner Almirall S.A. has licensed the rights to develop and commercialize EBGLYSS for the treatment of dermatology indications, including eczema, in Europe.
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