Phase III Trial meets Primary Endpoint for Patients with Eosinophilic Granulomatosis with Polyangiitis (EGPA)

 

Patients with severe asthma with an eosinophilic phenotype who are 12 years of age or older may now receive treatment with FASENRA as an add-on maintenance treatment. Note that FASENRA is not indicated for treatment of other eosinophilic conditions.

According to a report published in Inside Precision Medicine, eosinophilic granulomatosis with polyangiitis (EPGA) is an immune-mediated disease caused by inflammation of blood vessels that are small to medium in size. Estimates are that there are about 118,000 people in the world who have been diagnosed with EGPA.

The disease may affect various organs such as the lungs, heart, skin, nerves, and the gastrointestinal tract.

The common symptoms are extreme fatigue, joint and muscle pain, weight loss, nasal symptoms and sinus, rashes, nerve pain, and difficulty breathing. EGPA may be fatal if left untreated.

About Eosinophils

Patients with EGPA usually have high levels of eosinophils (white blood cells) in the peripheral blood and in the tissues and organs that are infected.

An eosinophil is a type of white blood cell. It is a granulocyte, which means it releases granules of enzymes to fight foreign substances and infections. Nearly every system in the body uses eosinophils.

However, the options to treat eosinophilic granulomatosis with polyangiitis are limited. EGPA guidelines suggest beginning with two to three weeks of prednisolone and then tapering off after three to six months. Patients are often prescribed high-dose corticosteroids together with Cytoxan® or other immunosuppressive drugs.

Patients may also be treated with chronic high-dose OCS and can experience recurrent relapses when attempting to taper off. Mepolizumab is currently the only approved treatment for EGPA.

About MANDARA


MANDARA was a 52-week Phase III trial with 140 participants that compared the safety and efficacy of FASENRA to mepolizumab in patients with r/r EGPA. Mepolizumab is a humanized IL-5 antagonist monoclonal antibody. Patients received either one 30mg FASENRA injection or three 100mg injections of mepolizumab at four-week intervals.

Patients who completed the 52-week treatment may be eligible to transfer into an extension period, allowing each patient a minimum of one year of treatment with FASENRA.

About FASENRA


FASENRA (benralizumab), developed by AstraZeneca, is currently approved as a maintenance treatment add-on in the US, Japan, and the EU as well as other countries. It is also approved for self-administration in the EU, US, and other regions. FASENRA has been studied in approximately 4,000 patients in international clinical trials.

About AstraZeneca


AstraZeneca is an international biopharmaceutical company that focuses on the discovery, commercialization, and development of prescription medicines in biopharmaceuticals and oncology.