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Mepolizumab, sold under the brand name Nucala by GlaxoSmithKline, is a humanized monoclonal antibody used for the treatment of severe eosinophilic asthma, eosinophilic granulomatosis with polyangiitis, and hypereosinophilic syndrome (HES). It recognizes and blocks interleukin-5 (IL-5), a signalling protein of the immune system.
The most common side effects include headache, injection site reactions, and back pain.
In studies, mepolizumab cut the necessity for hospitalisation due to asthma in half, as compared to placebo.
In December 2017, the FDA expanded mepolizumab's indication to treat adults with eosinophilic granulomatosis with polyangiitis, which is a rare autoimmune condition that can cause vasculitis.
In September 2020, the FDA expanded mepolizumab's indication to treat adults and children aged twelve years and older with hypereosinophilic syndrome (HES) for six months or longer without another identifiable non-blood related cause of the disease.
The most common side effects in people with hypereosinophilic syndrome (HES) include: upper respiratory tract infection and pain in extremities (such as the hands, legs and feet).
Mepolizumab was approved for medical use in the European Union in December 2015.
In September 2020, mepolizumab was approved in the United States to treat adults and children aged twelve years and older with hypereosinophilic syndrome (HES) for six months or longer without another identifiable non-blood related cause of the disease.
In January 2024, mepolizumab was approved in China for use in severe asthma with an eosinophilic phenotype.
Mepolizumab was evaluated in a randomized, double-blind, multicenter, placebo-controlled trial in 108 participants with hypereosinophilic syndrome (HES). In the study, participants were randomly assigned to receive mepolizumab or placebo by injection every four weeks. The trial compared the proportion of subjects who experienced a HES flare during the 32-week treatment period. A HES flare was defined as worsening of clinical signs and symptoms of HES or increasing eosinophils (disease-fighting white blood cells) on at least two occasions. The trial compared the proportions of participants with at least one flare over a 32-week treatment period, as well as the time to the first flare. Fewer participants in the mepolizumab treatment group (28%) had HES flares compared to participants in the placebo group (56%), with a 50% relative reduction. In addition, the time to the first HES flare was later, on average, for participants treated with mepolizumab versus placebo.
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