BEACON TRANSCRIPT – FDA approves new treatment for asthma in the course of maintenance treatment for severe cases. The U.S. Food and Drug Administration has given the green light to the use of mepolizumab (produced under the name Nucala by GlaxoSmithKline) as treatment in severe cases of asthma for patients of 12 years or older with an eosinophilic phenotype.
It is only allowed as part of a maintenance treatment for patients whose diagnosis fits all of these requirements and cannot be used to treat other eosinophilic conditions, nor can it be administered as an emergency treatment for other types of conditions such as acute bronchospasm or status asthmaticus.
According to Badrul Chowdhury, MD, PhD and director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research, the drug offers people an additional option when trying to keep their asthma under control and can’t manage to do so with the treatments they are currently using.
Mepolizumab is a drug that targets the underlying cause of a form of the disease caused by eosinophilic inflammation, so it can only be used to treat specific cases that are brought on by this type of inflammation. But the drug can help many patients bring their severe asthma under control while still on their regular medication.
The drug is an antibody that helps combat severe asthma attacks by lowering the body’s levels of serum eosinophils. It is administered alongside the patient’s regular treatment in the form of a subcutaneous injection in the upper arm, abdomen or thigh once every four weeks.
The trial the drug underwent before being approved were aimed at establishing both its efficacy and how safe it is to use and was conducted on patients with severe asthma who were already taking available treatments. Patients were given either the drug or a placebo every four weeks as an add-on to their regular asthma medication.
It was determined that patients taking the drug experienced fewer exacerbations that required hospitalization or emergency care, and the time it took them to experience the first exacerbation was longer than the one for patients who took placebo.
Patients using the drug during the testing were also able to cut down on their daily oral corticosteroid dose while still managing to keep their asthma under control compared to patients in the placebo group.
The side effects most commonly reported by patients were injection-site reactions, headaches, fatigue and back pain. The drug has now been approved as an add-on maintenance treatment for severe cases of refractory eosinophilic asthma in the U.S. and has also been recommended for approval by the Committee for Medicinal Products for Human Use of the European Medicines Agency.
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