Is Ebglyss (Lebrikizumab) on the market?

In November 2023, lebrikizumab was approved by the European Medicines Agency (EMA) under the trade name Ebglyss for the treatment of moderate to severe atopic dermatitis (AD) in adult and adolescent patients aged 12 years and older and weighing at least 40kg. The approval is based on positive results from Phase 3 studies (ADvocate 1 and 2), in which nearly 80% of patients achieved skin clearance, itch relief and reduction in disease severity at week 16 when taking lebrikizumab as monotherapy or in combination with topical corticosteroids.

Ebglyss was also approved by the U.S. Food and Drug Administration (FDA) on September 13, 2024, for the treatment of moderate to severe atopic dermatitis (eczema) that is not well controlled despite topical prescription treatments in people weighing at least 88 pounds (40kg). Ebglyss is a monoclonal antibody that binds IL-13 with high affinity and slower shedding rate. It binds to a different epitope than tralokinumab. Eczema inflammation under the skin can cause symptoms that are visible and tangible on the outside. EBGLYSS works by targeting eczema inflammation throughout the body that causes dry, itchy, and inflamed skin.

Ebglyss has been shown to reduce the extent and severity of atopic dermatitis in patients with moderate to severe atopic dermatitis, for whom available treatments are limited. EBGLYSS 250 mg/2 mL injection can be used with or without topical corticosteroids and is administered as a monthly maintenance injection after the initial period of treatment. The recommended initial dose of Ebglyss is 500 mg (two 250 mg injections) at Weeks 0 and 2, followed by 250 mg every two weeks until adequate clinical response is achieved at or after Week 16; thereafter, the maintenance dose is monthly injections (250 mg every four weeks).

Regarding safety,Ebglyss side effects usually occur at the beginning of treatment and are usually mild and manageable. The most common side effects include injection site reactions, dry eye, and conjunctivitis (eye redness and discomfort).