Lebrikizumab

Lebrikizumab, sold under the brand name Ebglyss is a humanized monoclonal antibody used for the treatment of atopic dermatitis (atopic eczema).

The most common side effects include injection site reactions, dry eye and conjunctivitis (redness and discomfort in the eye) including allergic conjunctivitis.

It was approved for medical use in the European Union in November 2023.

Medical uses
Lebrikizumab is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents twelve years and older with a body weight of at least 40 kg who are candidates for systemic therapy.

Mechanism of action
Lebrikizumab blocks interleukin 13 (IL-13), a cytokine (cell-signalling protein) that is produced by a type of white blood cell called Th2 cells. IL-13 is thought to induce the expression of another signalling protein, periostin, by epithelial cells of the bronchi. Periostin in turn seems to partake in a number of asthma related problems, such as bronchial hyperresponsiveness, inflammation, and activation and proliferation of airway fibroblasts, which are involved in airway remodelling.

This theory is supported by the fact that people with high periostin levels responded significantly better to lebrikizumab in the phase II study: the forced expiratory volume in 1 second (FEV1) was 8.2% higher than under placebo in this group (measured from the respective baselines), while low-periostin patients had 1.6% higher FEV1, and the average value for all patients was 5.5%. The FEV1 increase in low-periostin patients was not statistically significant.

Legal status
In September 2023, the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended authorizing lebrikizumab (Ebglyss) for the treatment of atopic dermatitis. Lebrikizumab was approved for medical use in the European Union in November 2023.

In September 2023, the US Food and Drug Administration declined to approve lebrikizumab due to certain findings during an inspection of a contract manufacturer, unrelated to the clinical trial data, safety, or label for lebrikizumab.

Brand names
Lebrikizumab is the international nonproprietary name.

Lebrikizumab is sold under the brand name Ebglyss.

Research
Lebrikizumab is under investigation as an immunosuppressive medication for the treatment of asthma that cannot be adequately controlled with inhalable glucocorticoids. It was created by Tanox under the code name TNX-650, and a phase I clinical trial for refractory Hodgkin’s lymphoma had been performed when Genentech acquired Tanox in 2007. It has successfully completed a Phase II clinical trial for the treatment of asthma.