September 18, 2024: The US Food and Drug Administration approved AstraZeneca Plc’s Fasenra for treatment in adult patients with a rare inflammation of blood vessels.
The FDA nod came after a trial that compared the efficacy and safety of the injection to mepolizumab —the sole approved treatment for the disease, according to a statement from AstraZeneca, a British-Swedish company.
About 60% of Fasenra–treated patients achieved remission which was comparable to mepolizumab-treated patients. Data also showed that 41% of Fasenra–treated patients fully stopped taking oral corticosteroids compared to 26% in the mepolizumab arm.
Eosinophilic granulomatosis with polyangiitis (EGPA) is an extremely rare form of vasculitis, characterized by inflammation within small blood vessels.
Blood flow restricted
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.
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.
‘Taper off steroid therapy’
“Patients often rely on long-term oral corticosteroids, which can cause serious and lasting side effects,” said Dr Michael Wechsler, Professor of Medicine and Director of The Asthma Institute at National Jewish Health, and International Coordinating Investigator of the trial.
“Benralizumab is a much-needed treatment option, with data showing that not only is remission an achievable goal for EGPA patients, but benralizumab can also help patients taper off steroid therapy.”
Results from the end-stage trial were published in The New England Journal of Medicine.
Joyce Kullman, Executive Director of Vasculitis Foundation said: “This disease has a devastating impact on patients and the quality of their life, and they need more treatment options,” and would benefit patients living in the US with this “difficult-to-treat rare disease.”
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.
Eosinophilic diseases
“Fasenra is already well established for the treatment of severe eosinophilic asthma, and with this approval, physicians in the US will now be able to offer an important new, convenient single monthly subcutaneous injection to their patients with EGPA,” said Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca.
“Today’s news demonstrates the potential of Fasenra to help patients suffering from eosinophilic diseases beyond severe asthma.”
The drug is currently approved as an add-on maintenance treatment for severe eosinophilic asthma in more than 80 countries including the US, Japan, EU 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.
It was developed by AstraZeneca and is in-licensed from BioWa, Inc., a wholly-owned subsidiary of Kyowa Kirin Co., Ltd., Japan.
