AstraZeneca (AZ) has announced that its Fasenra (benralizumab) has received expanded approval from the US Food and Drug Administration (FDA) as an add-on maintenance treatment for paediatric patients aged six to 11 years with severe eosinophilic asthma (SEA).
The approval was based on evidence from the open-label phase 3 TATE trial in addition to well-controlled trials in adult and adolescent populations.
Asthma is one of the most common chronic childhood diseases and causes coughing, wheezing and difficulty breathing.
SEA is a serious form of asthma that occurs when white blood cells known as eosinophils become overreactive and cause inflammation in the lungs and airways.
Fasenra is a monoclonal antibody that binds directly to IL-5 receptor alpha on eosinophils, attracting cells to deplete blood and tissue eosinophils in most patients via programmed cell death.
Results from the TATE study demonstrated that Fasenra met its primary endpoints after exhibiting pharmacokinetics and pharmacodynamics in paediatric patients aged six to 11 years with SEA, which were consistent with those seen in previous trials, as well as its safety and tolerability.
Administered via a subcutaneous injection, the recommended dose for Fasenra in patients aged six and older who weigh 35kg or more is 30mg, while paediatric patients aged six to 11 years who weigh less than 35kg will now require a 10mg dose.
Liz Bodin, vice president, US respiratory and immunology, AZ, said: “Expanding options for children whose quality of life has been drastically impacted by SEA with the help of Fasenra is an exciting step in our mission to revolutionise asthma care.”
Chief audit executive and chief executive officer of the Allergy and Asthma Network, Lynda Mitchell, commented: “We welcome additional treatment options for children living with severe asthma… further helping to address the unmet need in this patient population and reducing the burden of disease for the broader asthma community.”
Already authorised in more than 80 countries, Fasenra was first approved by the FDA in 2017, as an add-on maintenance treatment for paediatric patients aged 12 years and older with SEA.
The monoclonal antibody is also currently in development to treat other diseases, including chronic obstructive pulmonary disease, chronic rhinosinusitis with nasal polyps and hypereosinophilic syndrome.