AstraZeneca has announced that its FASENRA (benralizumab) has been approved by the US Food and Drug Administration (FDA) for the treatment of adult and paediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) without an identifiable non-haematologic secondary cause.
AstraZeneca said in its statement that the FDA's approval was based on positive results from the NATRON Phase III trial, in which treatment with FASENRA delayed the time to first HES flare and reduced the risk of first HES flare by 65% compared to placebo.
HES is a group of rare disorders marked by high levels of eosinophils, a type of white blood cell, in the blood.
This can cause damage to organs and tissues and if untreated, may lead to progressive organ damage or be fatal.
The most common adverse reactions with FASENRA in the NATRON study were headache, hypersensitivity reactions (including urticaria, urticaria papular, rash) and influenza-like illness.
For the treatment of HES, the recommended dosage of FASENRA is 30 mg (one injection) administered subcutaneously once every four weeks.
Princess U. Ogbogu, Division Chief of Pediatric Allergy, Immunology and Rheumatology at University Hospitals Rainbow Babies and Children’s Hospital and Case Western Reserve University, Cleveland, OH and principal investigator of the NATRON trial, said: "The approval of benralizumab for the treatment of HES is an important step forward for patients, providing an additional treatment option."
The study demonstrated a meaningful reduction in flares while addressing fatigue, a symptom that may impact patients.
James Teague, Vice President, US Respiratory & Immunology and Vaccine & Immune Therapies, AstraZeneca, added: "This approval builds on FASENRA's foundation in targeting eosinophilic-driven diseases."
FASENRA has been shown to reduce flares in hypereosinophilic syndrome, addressing an important need in a population with significant disease burden and few targeted therapies.
FASENRA is currently approved as an add-on maintenance treatment for severe eosinophilic asthma (SEA) in more than 80 countries, including the US, Japan, the European Union and China.
It is also approved for treating SEA in children and adolescents aged six years and older in both the US and Japan.
Additionally, FASENRA is approved in more than 70 countries for the treatment of adults with eosinophilic granulomatosis with polyangiitis (EGPA). In Chile, FASENRA is approved for the treatment of hypereosinophilic syndrome.