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FASENRA Receives Approval for Severe Asthma Treatment in Children Ages 6 to 11

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AstraZeneca’s FASENRA® (benralizumab) has received approval from the US Food and Drug Administration (FDA) as an add-on maintenance treatment for severe asthma patients aged 6 to 11 with an eosinophilic phenotype. This expansion of FASENRA’s indication builds upon its initial approval in 2017 for patients aged 12 and older with severe eosinophilic asthma (SEA).

The decision to extend FASENRA’s use in younger patients was supported by robust evidence from the TATE study, a Phase III trial conducted across multiple sites. Results from the TATE trial demonstrated that FASENRA’s pharmacokinetics (PK) and pharmacodynamics (PD) in children aged 6 to 11 with SEA were consistent with previous findings in adult and adolescent populations.

The safety and tolerability profile of FASENRA observed in the trial remained in line with its known profile. The recommended dosage for FASENRA in patients aged 6 years and older weighing 35 kg or more is 30 mg, while a new 10 mg dose will be available for patients aged 6 to 11 weighing less than 35 kg. FASENRA is administered via subcutaneous injection every 4 weeks for the first 3 doses, followed by administration every 8 weeks thereafter.

A Transformative Step for Children With Severe Asthma and Their Families

Lynda Mitchell, CEO of the Allergy & Asthma Network, welcomed the approval of FASENRA for the treatment of severe asthma in children, emphasizing the critical need for additional therapeutic options for pediatric patients contending with this debilitating condition. Asthma stands as the most prevalent chronic childhood disease, affecting millions of children worldwide. Its hallmark symptoms, including persistent coughing, wheezing, and breathing difficulties, not only pose immediate health concerns but also exert a profound impact on children’s daily lives and well-being.

For children with severe asthma, the burden is particularly pronounced, extending beyond physical discomfort to encompass a myriad of challenges that significantly impair their quality of life. Impaired school performance is a common consequence, as frequent asthma exacerbations and associated symptoms can disrupt classroom attendance, concentration, and academic achievement. Moreover, the limitations imposed by severe asthma can impede participation in extracurricular activities, social interactions, and overall childhood experiences, exacerbating feelings of isolation and diminishing self-esteem.

In addition to the direct effects on children, severe asthma exerts a considerable toll on families, caregivers, and healthcare systems. The relentless cycle of managing asthma symptoms, attending medical appointments, and navigating treatment regimens places immense strain on families, often requiring substantial time, resources, and emotional investment. Moreover, the economic burden associated with severe asthma is substantial, encompassing healthcare expenditures, missed workdays for caregivers, and productivity losses attributable to childhood absenteeism and reduced educational attainment.

Severe Asthma

The Impact of FASENRA’s Approval on Severe Asthma Management

In light of these challenges, the approval of FASENRA for pediatric use represents a significant advancement in pediatric asthma care, offering hope to children and families grappling with the complexities of severe asthma management. By expanding the armamentarium of available treatments, FASENRA provides healthcare providers with a valuable tool to better address the diverse needs of pediatric patients and mitigate the adverse impacts of severe asthma on their health and quality of life.

As CEO of the Allergy & Asthma Network, Mitchell’s optimism about the approval underscores the collective desire within the medical community to improve outcomes and enhance the well-being of children living with severe asthma. Through ongoing research, advocacy, and collaboration, stakeholders across the healthcare landscape are committed to advancing pediatric asthma care, ensuring that every child has access to effective treatments and the opportunity to thrive despite the challenges posed by this chronic condition.

Liz Bodin, Vice President of US Respiratory & Immunology at AstraZeneca, emphasized the company’s commitment to improving asthma care and addressing the needs of patients. With FASENRA having already positively impacted over 100,000 patients in the US, Bodin views the approval as a significant milestone in advancing asthma treatment.

Enhancing Asthma Care for Children with Key Safety Considerations

In addition to its approval for severe asthma treatment in children aged 6 and older, FASENRA carries important safety considerations and contraindications. Hypersensitivity reactions, acute asthma symptoms, and reduction of corticosteroid dosage are among the warnings and precautions associated with FASENRA use. Common adverse reactions include headache and pharyngitis, with injection site reactions also reported in a small percentage of patients.

The broader context of FASENRA’s approval underscores AstraZeneca’s dedication to respiratory care and its mission to revolutionize asthma treatment. With ongoing research and development efforts, AstraZeneca aims to extend FASENRA’s utility to other diseases, including chronic obstructive pulmonary disease and chronic rhinosinusitis with nasal polyps.

Overall, the approval of FASENRA for severe asthma treatment in children aged 6 to 11 represents a significant advancement in addressing the unmet needs of pediatric asthma patients and underscores AstraZeneca’s commitment to respiratory and immunology research and innovation.


Resource: Astrazeneca, April 11, 2024

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