{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,4]],"date-time":"2026-09-04T16:58:09Z","timestamp":1788541089432,"version":"build-2803163510"},"reference-count":12,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2024,10,16]],"date-time":"2024-10-16T00:00:00Z","timestamp":1729036800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clin Pharma and Therapeutics"],"published-print":{"date-parts":[[2025,2]]},"abstract":"<jats:p>On October 6, 2023, the US Food and Drug Administration (FDA) approved an intravenous (IV) formulation and dosage of Cosentyx\u00ae (secukinumab), for the treatment of adult patients with active psoriatic arthritis (PsA), active ankylosing spondylitis (AS), and active non\u2010radiographic axial spondyloarthritis (nr\u2010axSpA) with objective signs of inflammation. Clinical pharmacokinetics (PK), efficacy, and short\u2010term placebo\u2010controlled safety data were available from clinical studies (NCT04156620 and NCT04209205) with the to\u2010be\u2010marketed IV formulation using a maintenance dosage 3\u2009mg\/kg every 4\u2009weeks (q4w), which was different from the dose approved (1.75\u2009mg\/kg q4w). The IV dosage of 3\u2009mg\/kg utilized in these two trials resulted in exposures (<jats:italic>C<\/jats:italic><jats:sub>max,ss<\/jats:sub>) significantly higher than those for the approved subcutaneous (SC) regimens. Further, there is limited long\u2010term safety information available for this 3\u2009mg\/kg q4w IV dose. To address this important limitation, a model\u2010informed drug development (MIDD) approach was employed to leverage available clinical PK, efficacy, and safety data from the secukinumab development program to identify a maintenance IV dosing regimen, 1.75\u2009mg\/kg IV q4w, that better approximated the relevant SC secukinumab exposures for which efficacy and safety have been established. The MIDD analyses were used to support approval of this IV dosing regimen not directly studied in the indications sought for licensure, PsA, AS, and nr\u2010AxSpA.<\/jats:p>","DOI":"10.1002\/cpt.3464","type":"journal-article","created":{"date-parts":[[2024,10,16]],"date-time":"2024-10-16T10:09:59Z","timestamp":1729073399000},"page":"475-484","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Model\u2010Informed Drug Development\u2010Based Approval of Intravenous Secukinumab for the Treatment of Adult Patients with Active Psoriatic Arthritis, Active Ankylosing Spondylitis, and Active Non\u2010Radiographic Axial Spondyloarthritis"],"prefix":"10.1002","volume":"117","author":[{"ORCID":"https:\/\/orcid.org\/0009-0003-0551-3892","authenticated-orcid":false,"given":"Dipak S.","family":"Pisal","sequence":"first","affiliation":[{"name":"Division of Inflammation and Immune Pharmacology, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2549-9528","authenticated-orcid":false,"given":"Yangbing","family":"Li","sequence":"additional","affiliation":[{"name":"Division of Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3659-6654","authenticated-orcid":false,"given":"Amit","family":"Golding","sequence":"additional","affiliation":[{"name":"Division of Rheumatology and Transplant Medicine, Office of Immunology and Inflammation, Office of New Drug, Center for Drug Evaluation and Research Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-4099-0166","authenticated-orcid":false,"given":"Raj","family":"Nair","sequence":"additional","affiliation":[{"name":"Division of Rheumatology and Transplant Medicine, Office of Immunology and Inflammation, Office of New Drug, Center for Drug Evaluation and Research Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nikolay P.","family":"Nikolov","sequence":"additional","affiliation":[{"name":"Office of Immunology and Inflammation, Office of New Drug, Center for Drug Evaluation and Research Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rajanikanth","family":"Madabushi","sequence":"additional","affiliation":[{"name":"Guidance and Scientific Policy, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3858-2048","authenticated-orcid":false,"given":"Hao","family":"Zhu","sequence":"additional","affiliation":[{"name":"Division of Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-4519-6741","authenticated-orcid":false,"given":"Suresh","family":"Doddapaneni","sequence":"additional","affiliation":[{"name":"Division of Inflammation and Immune Pharmacology, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chandrahas","family":"Sahajwalla","sequence":"additional","affiliation":[{"name":"Division of Inflammation and Immune Pharmacology, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Youwei","family":"Bi","sequence":"additional","affiliation":[{"name":"Division of Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0004-7585-0701","authenticated-orcid":false,"given":"Jianmeng","family":"Chen","sequence":"additional","affiliation":[{"name":"Division of Inflammation and Immune Pharmacology, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,10,16]]},"reference":[{"key":"e_1_2_11_1_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra1505557"},{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41584-022-00776-6"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra1406182"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/acr.24025"},{"key":"e_1_2_11_5_1","unstructured":"COSENTYX\u00ae (secukinumab) injection USPIhttps:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2023\/761349s000lbl.pdf."},{"key":"e_1_2_11_6_1","doi-asserted-by":"crossref","DOI":"10.1038\/s41584-020-0496-z","article-title":"Secukinumab effective for nr\u2010axSpA","volume":"16","author":"Onuora S.","year":"2020","journal-title":"Nat. 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