HQ Team
October 28, 2024: AstraZeneca Plc’s drug Fasenra got approval from the European Union regulator for treating adult patients with a rare inflammation of blood vessels.
The condition is called relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA), which can result in damage to multiple organs including lungs, upper airway, skin, heart, gastrointestinal tract and nerves, and without treatment, can be fatal.
The EU nod came after an end-stage trial showed nearly 60% of Fasenra-treated patients achieved remission, which was comparable to mepolizumab-treated patients — the sole approved treatment for the disease.
The European Commission’s green light followed a positive opinion from the Committee for Medicinal Products for Human Use.
Oral corticosteroids
Data also showed that 41% of patients treated with Fasenra fully stopped taking oral corticosteroids compared to 26% in the mepolizumab arm.
“People living with EGPA suffer debilitating symptoms, organ damage and even death. Today’s approval provides an important treatment option for people living with EGPA in the EU,” said Bernhard Hellmich, Principal Investigator of the trial.
“By directly targeting and removing eosinophilic inflammation with benralizumab, I hope that we will see more patients achieve remission as well as a reduction in the reliance on oral corticosteroids, which can cause serious and long-term side effects.”
It was developed by AstraZeneca and is in-licensed from BioWa, Inc., a wholly-owned subsidiary of Kyowa Kirin Co., Ltd., Japan.
Inflammation in small blood vessels
Eosinophilic granulomatosis with polyangiitis is an extremely rare form of vasculitis, characterized by inflammation within small blood vessels.
This inflammation results in blood flow restriction, which can cause organ damage throughout the body if left untreated.
The ultra-rare disease affects about 50,000 people in the United States, according to the National Lung Association. EGPA affects people differently, depending on which organs are affected by the disease as well as the severity.
It affects men and women and can occur at any age, though the average age of diagnosis is between 35 and 50 years old. It is estimated that 118,000 people throughout the world live with EGPA.
The most common symptoms and signs include extreme fatigue, weight loss, muscle and joint pain, rashes, nerve pain, sinus and nasal symptoms, and shortness of breath.
About half of patients with EGPA have adult-onset severe eosinophilic asthma and often have sinus and nasal symptoms. Fasenra is only the second biologic approved to treat this disease.
‘Single-monthly injection’
“Today’s approval of Fasenra, with its convenient, single-monthly injection, is a positive step forward for patients with EGPA,” said Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit of AstraZeneca.
The US Food and Drug Administration approved AstraZeneca Plc’s Fasenra for treatment in adult patients with a rare inflammation of blood vessels in September 2024.
The drug is currently approved as an add-on maintenance treatment for severe eosinophilic asthma in more than 80 countries, including Japan and China.
It is also approved in children and adolescents ages six and above in the US and Japan. The FDA granted Orphan Drug Designation for Fasenra for EGPA in 2018.
