{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,28]],"date-time":"2025-12-28T15:16:13Z","timestamp":1766934973803,"version":"3.41.2"},"reference-count":38,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2024,10,13]],"date-time":"2024-10-13T00:00:00Z","timestamp":1728777600000},"content-version":"vor","delay-in-days":12,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2024,10]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Purpose<\/jats:title><jats:p>Research and regulatory approval for pediatric uses of prescription drugs often lag years after adult approvals, during which time substantial off\u2010label use of medications in children can occur. We evaluated whether US Food and Drug Administration (FDA) regulatory actions affected the pediatric use of omalizumab, a biologic drug used to treat asthma.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>In this serial cross\u2010sectional study, we identified quarterly cohorts of children (0\u201318\u2009years) with moderate\u2010to\u2010severe asthma within two large national claims databases of those with commercial insurance and Medicaid from 2003 to 2019. Using an interrupted time\u2010series analysis, we fit segmented linear regression models to identify changes in the incidence of omalizumab use in 6\u201311\u2010year\u2010old children compared with 12\u201318\u2010year\u2010olds after two time points: (1) 2009Q3 when an FDA advisory committee voted against use for 6\u201311\u2010year\u2010old children and (2) 2016Q2 when FDA expanded omalizumab's labeling to include 6\u201311\u2010year\u2010old children.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>We identified 9298 new pediatric omalizumab users (84% Medicaid). Among 6\u201311\u2010year\u2010old children, the incidence of omalizumab use did not change following the FDA's initial review of evidence in 2009 and increased after 2016 Q2 FDA approval for this age group in both Medicaid (58 per 100\u2009000 children with asthma, 95% confidence interval [CI] 27\u201389, <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001) and commercial insurance (57 per 100\u2009000, 95% CI 21\u201394, <jats:italic>p<\/jats:italic>\u2009=\u20090.003) compared with 12\u201318\u2010year\u2010old children.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The use of omalizumab among asthmatic children aged 6\u201311\u2009years remained steady after FDA advisory committee concerns in 2009 and increased after FDA expanded the indication to include this population in 2016. Additional market incentives may help to ensure the timely generation of evidence and regulatory approval of medications for children.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.70009","type":"journal-article","created":{"date-parts":[[2024,10,14]],"date-time":"2024-10-14T03:07:32Z","timestamp":1728875252000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Use of Omalizumab for Pediatric Asthma After US Food and Drug Administration Expanded Indications"],"prefix":"10.1002","volume":"33","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7232-685X","authenticated-orcid":false,"given":"Anjali\u00a0D.","family":"Deshmukh","sequence":"first","affiliation":[{"name":"Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine Brigham and Women's Hospital  Boston Massachusetts USA"},{"name":"Georgia State University College of Law  Atlanta Georgia USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Aaron\u00a0S.","family":"Kesselheim","sequence":"additional","affiliation":[{"name":"Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine Brigham and Women's Hospital  Boston Massachusetts USA"},{"name":"Harvard Medical School  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Theodore","family":"Tsacogianis","sequence":"additional","affiliation":[{"name":"Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine Brigham and Women's Hospital  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5776-3293","authenticated-orcid":false,"given":"Benjamin\u00a0N.","family":"Rome","sequence":"additional","affiliation":[{"name":"Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine Brigham and Women's Hospital  Boston Massachusetts USA"},{"name":"Harvard Medical School  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2024,10,13]]},"reference":[{"key":"e_1_2_12_2_1","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2019\u20101571"},{"key":"e_1_2_12_3_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamapediatrics.2018.3416"},{"key":"e_1_2_12_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/hec.4182"},{"key":"e_1_2_12_5_1","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2019\u20100896"},{"key":"e_1_2_12_6_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00431\u2010019\u201003556\u20109"},{"key":"e_1_2_12_7_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMhle1901265"},{"key":"e_1_2_12_8_1","doi-asserted-by":"publisher","DOI":"10.5863\/1551\u20106776\u201025.3.175"},{"key":"e_1_2_12_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2017.03.002"},{"key":"e_1_2_12_10_1","unstructured":"\u201cMost Recent National Asthma Data \u201daccessed April 15 2021 https:\/\/www.cdc.gov\/asthma\/most_recent_national_asthma_data.htm."},{"key":"e_1_2_12_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaip.2015.10.008"},{"key":"e_1_2_12_12_1","doi-asserted-by":"publisher","DOI":"10.1136\/thx.2008.106609"},{"key":"e_1_2_12_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2009.09.021"},{"key":"e_1_2_12_14_1","doi-asserted-by":"publisher","DOI":"10.1067\/mai.2003.49"},{"key":"e_1_2_12_15_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1009705"},{"key":"e_1_2_12_16_1","unstructured":"\u201cGenentech: Press Releases Thursday July 7 \u201daccessed May 23 2022 https:\/\/www.gene.com\/media\/press\u2010releases\/14632\/2016\u201007\u201007\/fda\u2010approves\u2010genentechs\u2010xolair\u2010omalizuma."},{"key":"e_1_2_12_17_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0152195"},{"key":"e_1_2_12_18_1","first-page":"1082","article-title":"Examining the Effect of FDA Approval of Risperdal for Pediatric Use on Prescribing Trends From 2005\u20132008","volume":"42","author":"Essick C. 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