Friday, the FDA approved Eli Lilly And Co’s (NYSE:LLY) Ebglyss (lebrikizumab-lbkz), a targeted IL-13 inhibitor, for 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 works by targeting eczema inflammation throughout the body that can lead to dry, itchy, and irritated skin.
Ebglyss, 250 mg/2 mL injection, can be used with or without topical corticosteroids and is dosed as a monthly maintenance injection following the initial phase of treatment.
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The recommended initial starting dose of Ebglyss is 500 mg (two 250 mg injections) at Week 0 and Week 2, followed by 250 mg every two weeks until Week 16 or later when adequate clinical response is achieved; after this, maintenance dosing is a single monthly injection (250 mg every four weeks).
The approval was based on results from the ADvocate 1, ADvocate 2, and ADhere studies, which included over 1,000 adults and children (aged 12 and older) with moderate-to-severe eczema who could not 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% with placebo), and 10% saw these results as early as four weeks.
Of those who experienced clear or almost-clear skin at Week 16, 77% maintained those results at one year with once-monthly dosing. 48% of responders switched from Ebglyss to placebo at Week 16, maintained these results at one year.
Similarly, in both studies, many people experienced itch relief with Ebglyss.
On average, 43% of people who took Ebglyss felt itch relief at 16 weeks (compared to 12% who took a placebo), and 5% felt relief as early as two weeks.
Of the people who felt itch relief at Week 16, 85% still felt that relief at one year of treatment with monthly maintenance dosing. Sixty-six percent of responders switched from Ebglyss to placebo at Week 16 maintained these results at one year.
Price Action: LLY stock is up 0.28% at $925.90 at last check Monday.
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