New for 2022: Food and Drug Administration Approvals of Pediatric Respiratory Medications

Byrne J. FDA Approves Nucala Prefilled Syringe for Children with Severe Asthma. Available from: https://www.biopharma-reporter.com/Article/2022/01/25/FDA-approves-Nucala-prefilled-syringe-for-children-with-severe-asthma [Last accessed: January 31, 2023].

Park B . FDA Approval Allows for Use of Dupixent Prefilled Pens in Younger Patients. 2022. Available from: https://www.empr.com/home/news/fda-approval-allows-for-use-of-dupixent-prefilled-pens-in-younger-patients/ [Last accessed: January 31, 2023].

Dellon ES , Rothenberg ME , Collins MH , et al. Dupilumab in adults and adolescents with eosinophilic esophagitis. N Engl J Med, 2022; 387(25):2317–2330.

FDA Approves First Treatment for Eosinophilic Esophagitis, a Chronic Immune Disorder. Available from: https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-eosinophilic-esophagitis-chronic-immune-disorder [Last accessed: January 31, 2023].

Brunk D . FDA Approves Dupilumab for Children With Eczema Aged 6 Months to 5 Years. 2022. Available from: https://www.medscape.com/viewarticle/975216 [Last accessed: January 31, 2023].

Paller AS , Simpson EL , Siegfried EC , et al. Dupilumab in children aged 6 months to younger than 6 years with uncontrolled atopic dermatitis: A randomised, double-blind, placebo-controlled, phase 3 trial. Lancet, 2022; 400(10356):908–919.

Papi A , Chipps BE , Beasley R , et al. Albuterol–Budesonide Fixed-Dose Combination Rescue Inhaler for Asthma. N Engl J Med, 2022; 386(22):2071–2083.

Israel E , Beasley RW , Panettieri RA , et al. Efficacy and Safety of Albuterol/Budesonide (PT027) in Mild-to-Moderate Asthma: Results of the DENALI Study. B93. BREAKTHROUGHS IN PEDIATRIC AND ADULT ASTHMA CLINICAL, TRIALS:A3414.

LaForce C , Chipps BE , Albers FC , et al. Albuterol/budesonide for the treatment of exercise-induced bronchoconstriction in patients with asthma: The TYREE study. Ann Allergy Asthma Immunol, 2022; 128(2):169–177.

FDA Approves Orkambi for Children With CF Ages 1 to 2 Years. 2022. Available from: https://www.cff.org/news/2022-09/fda-approves-orkambi-children-cf-ages-1-2-years [Last accessed: January 31, 2023].

Rayment JH , Asfour F , Rosenfeld M , et al. A phase 3, open-label study of lumacaftor/ivacaftor in children 1 to less than 2 years of age with cystic fibrosis homozygous for F508del-CFTR. Am J Respir Crit Care Med, 2022; 206(10):1239–1247.

Wexler M. #NACFC2022—Vertex Aiming to Expand Trikafta's Use, Better Treat CF. Available from: https://cysticfibrosisnewstoday.com/news/nacfc2022-vertex-aim-expand-trikafta-use-better-treat-cf/ [Last accessed: January 31, 2023].

Goralski J , Hoppe J , Mall M , McColley S. A phase 3 open-label study of elexacaftor/tezacaftor/ivacaftor in children 2 through 5 years of age with cystic fibrosis and at least one F508del allele. Paper presented at: North American Cystic Fibrosis Conference; November 3, 2022; Philadelphia, PA.

Vertex Pharmaceuticals Incorporated (VRTX) 41st Annual J.P. Morgan Healthcare Conference—(Transcript). Available from: https://seekingalpha.com/article/4568767-vertex-pharmaceuticals-incorporated-vrtx-41st-annual-j-p-morgan-healthcare-conference [Last accessed: January 31, 2023].

Willis TA. Therapeutic advances in spinal muscular atrophy. Paediatr Child Health, 2023; 33(1):23–28.

Finkel RS , Farrar MA , Vlodavets D , et al. RAINBOWFISH: Preliminary Efficacy and Safety Data in Risdiplam-Treated Infants with Presymptomatic SMA (P17–5.003). Paper presented at: Neurology 2022.

Coronavirus (COVID-19) Update: FDA Approves First COVID-19 Treatment for Young Children. Available from: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-approves-first-covid-19-treatment-young-children#:~:text=Today%2C%20the%20U.S.%20Food%20and,Hospitalized%2C%20or [Last accessed: January 31, 2023].

Ahmed A , Rojo P , Agwu A , et al. P168 Remdesivir in the treatment of children 28 days to <18 years of age hospitalised with COVID-19 in the CARAVAN study. Thorax, 2022; 77(Suppl. 1):A172–A173.

Baker J , Block SL , Matharu B , et al. Baloxavir Marboxil Single-dose Treatment in Influenza-infected Children: A Randomized, Double-blind, Active Controlled Phase 3 Safety and Efficacy Trial (miniSTONE-2). Pediatr Infect Dis J, 2020; 39(8):700–705.

Ikematsu H , Hayden FG , Kawaguchi K , et al. Baloxavir marboxil for prophylaxis against influenza in household contacts. N Engl J Med, 2020; 383(4):309–320.

Mazur NI , Terstappen J , Baral R , et al. Respiratory syncytial virus prevention within reach: the vaccine and monoclonal antibody landscape. Lancet Infect Dis, 2023; 23(1):e2–e21.

Larkin H. Investigational RSV vaccine given during pregnancy protects newborns. JAMA, 2022; 328(22):2201–2201.

Deterding R , Young LR , DeBoer EM , et al. Nintedanib in children and adolescents with fibrosing interstitial lung diseases. Eur Respir J, 2023; 61(2):2201512.

Rosenberg R , Abaluck B , Thein S . Combination of atomoxetine with the novel antimuscarinic aroxybutynin improves mild to moderate OSA. J Clin Sleep Med, 2022; 18(12):2837–2844.