Nucala Receives New Indication for Rare Blood Disorder

September 25, 2020 – The U.S. FDA has approved a new indication for Nucala® (mepolizumab), manufactured by GlaxoSmithKline. Nucala is now indicated to treat patients who are at least 12 years of age and have had hypereosinophilic syndrome (HES) for at least six months without an identifiable non- hematologic secondary cause. Nucala is the first and only biologic approved by the FDA to treat HES.

An estimated 5,000 patients in the United States are affected by HES, a rare blood disorder characterized by persistent and significant overproduction of eosinophils, a type of white blood cell. This overproduction can lead to inflammation and organ damage. Potential complications may range from fever and fatigue to serious cardiac and respiratory difficulties.

In a clinical study, 50% fewer patients on Nucala experienced an HES flare requiring an escalation in therapy compared to patients on a placebo. Participants in the study were treated with a current standard of care in addition to Nucala or placebo.

Recommended dosing under the new indication is 300mg once every four weeks, administered by a healthcare professional as three separate 100mg subcutaneous injections in the upper arm, thigh, or abdomen.

First FDA approved in 2015, Nucala is also indicated to treat eosinophilic asthma and eosinophilic granulomatosis with polyangiitis.