On Sept. 13, 2024, the U.S. Food and Drug Administration (FDA) approved another monoclonal antibody that inhibits the action of interleukin-13 (IL-13) to block the release of inflammatory substances, Ebglyss^™ (lebrikizumab-lbkz – Eli Lilly). It will be available in the coming weeks as therapy for individuals who are at least 12 years old and have moderate-to-severe atopic dermatitis that is not well controlled with topical prescription therapies. Administered subcutaneously (SC), recommended treatment with Ebglyss begins with one 500mg dose (two 250mg injections at the same time) for weeks zero and two, followed by 250mg once every two weeks until week 16 or when the clinical response is achieved. After this, the dosing is a single 250mg monthly injection. Ebglyss may be used alone or in combination with topical products. Prescribing information may be found here.

At a Glance

• Brand Drug: Ebglyss^™ (lebrikizumab-lbkz)
• Manufacturer: Eli Lilly
• Date Approved: Sept. 13, 2024
• Indication:  to treat adults and children 12 years of age and older who weigh at least 88 pounds (40kg) with moderate-to-severe atopic dermatitis (eczema) that is not well controlled despite treatment with topical prescription therapies
• Dosage Forms Available: 250mg/2mL prefilled pens or prefilled syringes with needle shield for SC injection
• Launch Date: In the coming weeks
• Estimated Annual Cost: $40,000 per year
• Atopic dermatitis (AD) is a common form of eczema, a group of chronic skin diseases that involve inflammation and cause itchy, irritated bumps, crusts, and scales on the skin. It usually begins in childhood, with most patients having a first episode before the age of five years. Symptoms may improve and worsen unpredictably. Inflammation and scratching eventually can thicken and toughen the skin.
• According to the Asthma and Allergy Foundation of America, around 7.3% of American adults (about 18 million people) have atopic dermatitis. Moderate-to-severe forms of the condition are estimated to affect approximately two of every five patients aged 18 years or older.
• Approval was based on three clinical trials comparing Ebglyss to placebo. Thirty-eight percent of patients taking Ebglyss achieved clear or almost clear skin compared to 12% with placebo as measured by the Investigator Global Assessment (IGA) at week 16. Of that 38%, 77% maintained those results at one year with once-monthly dosing. Ebglyss also achieved key secondary endpoints versus placebo in patients with AD, including early onset in skin clearance and itch relief.
• Initial therapy for atopic dermatitis usually is a topical corticosteroid, with higher potency products used to treat more severe forms of the condition. A calcineurin inhibitor, such as Elidel^® (pimecrolimus) cream may be used for patients who cannot use a corticosteroid or whose atopic dermatitis has not been cleared by topical corticosteroid treatment.
• Other monoclonal antibodies include Dupixent^® (dupilumab – Sanofi/Regeneron) injection, an interleukin-4 alpha receptor blocker, which is FDA-approved for treating patients as young as six months old who have moderate-to-severe atopic dermatitis that is not responding to topical therapy. Adbry^® (tralokinumab-ldrm – LEO Pharma) is another IL-13 indicated to treat moderate-to-severe atopic dermatitis for patients 12 years and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
• The most common adverse events included conjunctivitis, nasopharyngitis, and headache for Ebglyss-treated patients.