Introduction

The drug benralizumab (trade name: Fasenra) has been approved in Germany since January 2018 for the treatment of severe eosinophilic asthma in adults. The drug is an additional treatment option if treatment with high-dose corticosteroids and long-acting beta2 agonists is no longer enough to manage the symptoms.

People with asthma have an immune system that permanently tends to overreact. When the mucous membranes lining the lungs (bronchi) come into contact with certain irritants, the muscles of the airways may contract. Typical symptoms include episodes or "attacks" of wheezing, coughing and shortness of breath. Eosinophilic granulocytes are cells of the body's immune system. In eosinophilic asthma, patients have an increased number of these cells in their blood and phlegm.

Benralizumab is an antibody against a chemical messenger produced by the immune system. It is meant to weaken the immune response in the bronchi by reducing the number of eosinophilic granulocytes.

Application

The drug is available in pre-filled syringes at a dosage of 30 mg. The first three doses are injected into the stomach, the thigh, or the upper arm every four weeks. Afterwards, an injection is used every two months.

Other treatments

The standard treatments for people with severe eosinophilic asthma are an individual combination of inhaled corticosteroids and long-acting bronchodilators, tiotropium to widen the airways and, for certain types of severe allergic asthma, omalizumab. Short-term use of oral corticosteroids may also be an option to support the treatment.

Assessment

In 2018, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) wanted to look into the advantages and disadvantages of benralizumab compared with the standard treatments for adults with severe eosinophilic asthma.

But the manufacturer did not provide any suitable data with which to do the assessment.

More information

This information summarizes the main results of a review produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The review was commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of this review and the hearings received, the G-BA passed a resolution on the added benefit of benralizumab (Fasenra).