• Drug Coverage
  • Hypertrophic Cardiomyopathy (HCM)
  • Vaccines: 2023 Year in Review
  • Eyecare
  • Urothelial Carcinoma
  • Women's Health
  • Hemophilia
  • Heart Failure
  • Vaccines
  • Neonatal Care
  • Type II Inflammation
  • Substance Use Disorder
  • Gene Therapy
  • Lung Cancer
  • Spinal Muscular Atrophy
  • HIV
  • Post-Acute Care
  • Liver Disease
  • Pulmonary Arterial Hypertension
  • Safety & Recalls
  • Biologics
  • Asthma
  • Atrial Fibrillation
  • Type I Diabetes
  • RSV
  • COVID-19
  • Cardiovascular Diseases
  • Breast Cancer
  • Prescription Digital Therapeutics
  • Reproductive Health
  • The Improving Patient Access Podcast
  • Blood Cancer
  • Ulcerative Colitis
  • Respiratory Conditions
  • Multiple Sclerosis
  • Digital Health
  • Population Health
  • Sleep Disorders
  • Biosimilars
  • Plaque Psoriasis
  • Leukemia and Lymphoma
  • Oncology
  • Pediatrics
  • Urology
  • Obstetrics-Gynecology & Women's Health
  • Opioids
  • Solid Tumors
  • Autoimmune Diseases
  • Dermatology
  • Diabetes
  • Mental Health

FDA Updates Week of April 8: Fasenra Gets New Indication


In a slow week, the FDA has approved Fasenra for children 6 to 11 years of age with eosinophilic asthma, a rare form of asthma.

Fasenra Approved for Children with Severe Asthma

The FDA has approved AstraZeneca’s Fasenra (benralizumab) as an add-on maintenance treatment for children aged 6 to 11 with eosinophilic asthma. Fasenra was first approved in 2017 as an add-on maintenance for the treatment of severe eosinophilic asthma in patients aged 12 and older.

Eosinophilic asthma is a rare type of asthma where white blood cells called eosinophils are elevated, causing inflammation. Fasenra is a monoclonal antibody that binds to the IL-5 receptor alpha on eosinophils and leads to depletion of blood and tissue eosinophils.

This additional indication was supported by evidence from TATE, an open-label, phase 3 trial, as well as trials in adult and adolescent populations. In the TATE study, Fasenra met the primary endpoints, demonstrating pharmacokinetics and pharmacodynamics in the younger patient population that were consistent with those seen in prior trials.

The recommended dose is 30 mg for patients 6 years and older who weigh 35 kg or more. For patients aged 6 to 11 who weigh less than 35 kg, a new 10 mg dose will be available. Fasenra is administered by subcutaneous injection every four weeks for the first three doses, and then every eight weeks.

The list price for Fasenra is $5,511.41 per 30 mg dose. AstraZeneca says for people with employer or individual private insurance, the average out-of-pocket cost is $46 per dose. Some patients may pay as little as $0 for Fasenra and as little as $0 for its injection administration. For people with Medicare Advantage plans, the average out-of-pocket cost is $90 per dose

Related Videos
Video 2 - "Addressing Coexisting Conditions: Keys to Comprehensive Diabetes Care"
Video 1 - "The Influence of Social Determinants of Health on Diabetes Care and Outcomes"
Gabriela Hobbs, MD, and Timothy Mok, PharmD, BCPS, BCOP
Video 4 - "Enhancing Patient Understanding and Treatment Adherence"
Video 2 - "Overview of Treatments for Atopic Dermatitis"
Video 3 - "In-Office Procedures, Over-the-Counter Options, Treatment Delays, and Costs"
Video 6 - "Safety Analysis and Interpreting Results from MAJIC-PV"
Video 5 - "Key Findings from MAJIC-PV"
Related Content
© 2024 MJH Life Sciences

All rights reserved.