{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,16]],"date-time":"2026-05-16T12:13:14Z","timestamp":1778933594572,"version":"3.51.4"},"reference-count":14,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2025,11,27]],"date-time":"2025-11-27T00:00:00Z","timestamp":1764201600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Ibrain"],"published-print":{"date-parts":[[2025,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Myasthenia gravis (MG) is an autoimmune disorder driven by pathogenic IgG autoantibodies, leading to muscle weakness and impaired quality of life. Conventional immunosuppressant therapies are often limited by side effects and incomplete efficacy. Nipocalimab\u2010aahu (N\u2010a), recently FDA\u2010approved, is a novel neonatal Fc receptor (FcRn) antagonist that reduces circulating IgG levels, targeting the underlying disease mechanism. This review synthesizes evidence on N\u2010a's efficacy, safety, and clinical positioning. Phase 2 and 3 trials (Vivacity\u2010MG\/MG3) demonstrated that N\u2010a significantly improves the Myasthenia Gravis Activities of Daily Living (MG\u2010ADL) score compared to placebo, with a favorable safety profile. The most common adverse events were nasopharyngitis and headache, with no increased serious infection risk or clinically significant hypoalbuminemia. Compared to other biologics, N\u2010a offers a distinct mechanism, selective IgG reduction without broad immunosuppression and a convenient bi\u2010weekly dosing regimen. While it shows promise for reduced systemic immunosuppression and potentially greater efficacy in MG\u2010ADL improvement than some alternatives, cross\u2010trial comparisons are limited. Key limitations include the need for long\u2010term safety data and more research in underrepresented populations, including pediatric and seronegative patients. In conclusion, N\u2010a represents a significant advancement in generalized MG (gMG) treatment, providing a targeted, effective, and well\u2010tolerated option that addresses a key unmet need for patients with acetylcholine receptor (AChR) or muscle\u2010specific kinase (MuSK) antibody\u2010positive disease.<\/jats:p>","DOI":"10.1002\/ibra.70006","type":"journal-article","created":{"date-parts":[[2025,11,27]],"date-time":"2025-11-27T15:09:28Z","timestamp":1764256168000},"page":"524-530","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Nipocalimab\u2010aahu in generalised myasthenia gravis: A new Fc receptor\u2010targeted option for antibody\u2010positive patients"],"prefix":"10.1002","volume":"11","author":[{"ORCID":"https:\/\/orcid.org\/0009-0007-7995-9933","authenticated-orcid":false,"given":"Jawairya Muhammad","family":"Hussain","sequence":"first","affiliation":[{"name":"Department of Medicine Karachi Medical and Dental College Karachi Pakistan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-8225-7399","authenticated-orcid":false,"given":"Anoosha","family":"Ashfaq","sequence":"additional","affiliation":[{"name":"Department of Medicine Allama Iqbal Medical College Lahore Pakistan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0004-6584-3516","authenticated-orcid":false,"given":"Azka","family":"Shahid","sequence":"additional","affiliation":[{"name":"Department of Medicine Allama Iqbal Medical College Lahore Pakistan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-5185-6144","authenticated-orcid":false,"given":"Fatima","family":"Mudassir","sequence":"additional","affiliation":[{"name":"Department of Medicine Allama Iqbal Medical College Lahore Pakistan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,11,27]]},"reference":[{"key":"e_1_2_15_2_1","doi-asserted-by":"publisher","DOI":"10.25122\/jml-2020-0145"},{"key":"e_1_2_15_3_1","unstructured":"Drugs.com. Imaavy (nipocalimab\u2010aahu) FDA approval history. Accessed September 20 2025.https:\/\/www.drugs.com\/history\/imaavy.html"},{"key":"e_1_2_15_4_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000207937"},{"key":"e_1_2_15_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(24)00498-8"},{"key":"e_1_2_15_6_1","doi-asserted-by":"publisher","DOI":"10.1080\/14712598.2023.2185131"},{"key":"e_1_2_15_7_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40263-023-01000-z"},{"key":"e_1_2_15_8_1","unstructured":"Drugs.com. Ravulizumab dosage guide + max dose adjustments. Accessed August 18 2025.https:\/\/www.drugs.com\/dosage\/ravulizumab.html"},{"key":"e_1_2_15_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/ene.15872"},{"key":"e_1_2_15_10_1","unstructured":"Johnson & Johnson. Johnson & Johnson receives FDA approval for IMAAVYTM (nipocalimab\u2010aahu) a new FcRn blocker offering long\u2010lasting disease control in the broadest population of people living with generalized myasthenia gravis (gMG). July 17 2025 Accessed September 20 2025.https:\/\/www.jnj.com\/media-center\/press-releases\/johnson-johnson-receives-fda-approval-for-imaavytm-nipocalimab-aahu-a-new-fcrn-blocker-offering-long-lasting-disease-control-in-the-broadest-population-of-people-living-with-generalized-myasthenia-gravis-gmg"},{"key":"e_1_2_15_11_1","unstructured":"International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Hospital resource utilization and estimated costs associated with nipocalimab: post\u2010hoc analysis of the placebo\u2010controlled VIVACITY\u2010MG3 trial in generalized myasthenia gravis. May 18\u201022 2025 Accessed September 20 2025.https:\/\/www.ispor.org\/heor-resources\/presentations-database\/presentation-cti\/ispor-2025\/poster-session-2\/hospital-resource-utilization-and-estimated-costs-associated-with-nipocalimab-post-hoc-analysis-of-the-placebo-controlled-vivacity-mg3-trial-in-generalized-myasthenia-gravis"},{"key":"e_1_2_15_12_1","unstructured":"International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Cost per responder for FcRn inhibitors for generalized myasthenia gravis. May 5\u20108 2024 Accessed September 13 2025.https:\/\/www.ispor.org\/heor-resources\/presentations-database\/presentation\/intl2024-3897\/137915"},{"issue":"8","key":"e_1_2_15_13_1","first-page":"1637","article-title":"FcRn inhibitors: a novel option for the treatment of myasthenia gravis","volume":"18","author":"Zhu LN","year":"2022","journal-title":"Neural Regen Res"},{"key":"e_1_2_15_14_1","doi-asserted-by":"publisher","DOI":"10.3389\/fneur.2023.1229112"},{"key":"e_1_2_15_15_1","doi-asserted-by":"publisher","DOI":"10.1080\/14728214.2025.2458061"}],"container-title":["Ibrain"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/ibra.70006","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,13]],"date-time":"2025-12-13T05:54:31Z","timestamp":1765605271000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/ibra.70006"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,11,27]]},"references-count":14,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2025,12]]}},"alternative-id":["10.1002\/ibra.70006"],"URL":"https:\/\/doi.org\/10.1002\/ibra.70006","archive":["Portico"],"relation":{},"ISSN":["2313-1934","2769-2795"],"issn-type":[{"value":"2313-1934","type":"print"},{"value":"2769-2795","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,11,27]]},"assertion":[{"value":"2025-07-14","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-11-17","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-11-27","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}