{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,16]],"date-time":"2026-10-16T00:39:38Z","timestamp":1792111178564,"version":"4.4.0"},"reference-count":23,"publisher":"Springer Science and Business Media LLC","issue":"7","license":[{"start":{"date-parts":[[2023,4,6]],"date-time":"2023-04-06T00:00:00Z","timestamp":1680739200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"},{"start":{"date-parts":[[2023,4,6]],"date-time":"2023-04-06T00:00:00Z","timestamp":1680739200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Drugs"],"published-print":{"date-parts":[[2023,5]]},"DOI":"10.1007\/s40265-023-01866-9","type":"journal-article","created":{"date-parts":[[2023,4,6]],"date-time":"2023-04-06T07:05:15Z","timestamp":1680764715000},"page":"633-638","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":26,"title":["Efanesoctocog Alfa: First Approval"],"prefix":"10.1007","volume":"83","author":[{"given":"Susan J.","family":"Keam","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2023,4,6]]},"reference":[{"issue":"Suppl 6","key":"1866_CR1","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1111\/hae.14046","volume":"26","author":"A Srivastava","year":"2020","unstructured":"Srivastava A, Santagostino E, Dougall A, et al. WFH guidelines for the management of hemophilia, 3rd edition. Haemophilia. 2020;26(Suppl 6):1\u2013158.","journal-title":"Haemophilia"},{"key":"1866_CR2","doi-asserted-by":"publisher","first-page":"133","DOI":"10.1016\/j.yapd.2022.03.009","volume":"69","author":"S Cho","year":"2022","unstructured":"Cho S, Perry AM, Cheng AM, et al. Advances in hemophilia A management. Adv Pediatr. 2022;69:133\u201347.","journal-title":"Adv Pediatr"},{"issue":"16","key":"1866_CR3","doi-asserted-by":"publisher","first-page":"2007","DOI":"10.1182\/blood-2016-04-713289","volume":"128","author":"SW Pipe","year":"2016","unstructured":"Pipe SW, Montgomery RR, Pratt KP, et al. Life in the shadow of a dominant partner: the FVIII-VWF association and its clinical implications for hemophilia A. Blood. 2016;128(16):2007\u201316.","journal-title":"Blood"},{"issue":"9","key":"1866_CR4","doi-asserted-by":"publisher","first-page":"1957","DOI":"10.1111\/jth.15793","volume":"20","author":"KC Childers","year":"2022","unstructured":"Childers KC, Peters SC, Spiegel PC Jr. Structural insights into blood coagulation factor VIII: procoagulant complexes, membrane binding, and antibody inhibition. J Thromb Haemost. 2022;20(9):1957\u201370.","journal-title":"J Thromb Haemost"},{"issue":"21","key":"1866_CR5","doi-asserted-by":"publisher","first-page":"2970","DOI":"10.1182\/blood.2020009197","volume":"137","author":"JR Fuller","year":"2021","unstructured":"Fuller JR, Knockenhauer KE, Leksa NC, et al. Molecular determinants of the factor VIII\/von Willebrand factor complex revealed by BIVV001 cryo-electron microscopy. Blood. 2021;137(21):2970\u201380.","journal-title":"Blood"},{"issue":"10274","key":"1866_CR6","doi-asserted-by":"publisher","first-page":"630","DOI":"10.1016\/S0140-6736(20)32722-7","volume":"397","author":"ME Mancuso","year":"2021","unstructured":"Mancuso ME, Mahlangu JN, Pipe SW. The changing treatment landscape in haemophilia: from standard half-life clotting factor concentrates to gene editing. Lancet. 2021;397(10274):630\u201340.","journal-title":"Lancet"},{"issue":"11","key":"1866_CR7","doi-asserted-by":"publisher","first-page":"1018","DOI":"10.1056\/NEJMoa2002699","volume":"383","author":"BA Konkle","year":"2020","unstructured":"Konkle BA, Shapiro AD, Quon DV, et al. BIVV001 fusion protein as factor VIII replacement therapy for hemophilia A. N Engl J Med. 2020;383(11):1018\u201327.","journal-title":"N Engl J Med"},{"issue":"17","key":"1866_CR8","doi-asserted-by":"publisher","first-page":"1484","DOI":"10.1182\/blood.2019001292","volume":"135","author":"E Seth Chhabra","year":"2020","unstructured":"Seth Chhabra E, Liu T, Kulman J, et al. BIVV001, a new class of factor VIII replacement for hemophilia A that is independent of von Willebrand factor in primates and mice. Blood. 2020;135(17):1484\u201396.","journal-title":"Blood"},{"issue":"5","key":"1866_CR9","doi-asserted-by":"publisher","first-page":"835","DOI":"10.1111\/bjh.17580","volume":"194","author":"H Fassel","year":"2021","unstructured":"Fassel H, McGuinn C. Haemophilia: factoring in new therapies. Br J Haematol. 2021;194(5):835\u201350.","journal-title":"Br J Haematol"},{"key":"1866_CR10","unstructured":"Bioverativ Therapeutics Inc. Efanesoctocog alfa [antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl]: US prescribing information. 2023. https:\/\/www.altuviiio.com\/. Accessed 7 Mar 2023."},{"key":"1866_CR11","unstructured":"Sanofi. FDA approves once-weekly ALTUVIIIO\u2122, a new class of factor VIII therapy for hemophilia A that offers significant bleed protection [media release]. 23 Feb 2023. https:\/\/www.sanofi.com\/."},{"key":"1866_CR12","unstructured":"Swedish Orphan Biovitrum AB. FDA approves once-weekly efanesoctocog alfa, a new class of high-sustained factor VIII therapy for haemophilia A [media release]. 23 Feb 2023. https:\/\/www.sobi.com\/."},{"key":"1866_CR13","unstructured":"Swedish Orphan Biovitrum AB. Sobi strengthens haemophilia position with potential once-weekly haemophilia A treatment [media release]. 29 Sep 2019. https:\/\/www.sobi.com."},{"key":"1866_CR14","unstructured":"Sanofi. Sanofi completes acquisition of Amunix [media release]. 8 Feb 2022. https:\/\/www.sanofi.com."},{"key":"1866_CR15","unstructured":"Sanofi. Sanofi completes acquisition of Bioverativ Inc. [media release]. 8 Mar 2018. https:\/\/www.sanofi.com."},{"key":"1866_CR16","unstructured":"Amunix Inc. Biogen Idec signs license agreement with Amunix for XTENylated Factor VIII [media release]. 21 Apr 2014. https:\/\/www.amunix.com\/."},{"key":"1866_CR17","unstructured":"Amunix Inc. Amunix signs research collaboration with Biogen Idec for next generation long-lasting blood factor products [media release]. 13 Apr 2011. https:\/\/www.amunix.com\/."},{"key":"1866_CR18","doi-asserted-by":"publisher","first-page":"52","DOI":"10.1016\/j.jconrel.2015.10.038","volume":"240","author":"VN Podust","year":"2016","unstructured":"Podust VN, Balan S, Sim BC, et al. Extension of in vivo half-life of biologically active molecules by XTEN protein polymers. J Control Release. 2016;240:52\u201366.","journal-title":"J Control Release"},{"issue":"7","key":"1866_CR19","doi-asserted-by":"publisher","first-page":"1674","DOI":"10.1111\/jth.15741","volume":"20","author":"M Demers","year":"2022","unstructured":"Demers M, Aleman MM, Kistanova E, et al. Efanesoctocog alfa elicits functional clot formation that is indistinguishable to that of recombinant factor VIII. J Thromb Haemost. 2022;20(7):1674\u201383.","journal-title":"J Thromb Haemost"},{"issue":"4","key":"1866_CR20","doi-asserted-by":"publisher","first-page":"1089","DOI":"10.1182\/bloodadvances.2021006119","volume":"6","author":"T Lissitchkov","year":"2022","unstructured":"Lissitchkov T, Willemze A, Katragadda S, et al. Efanesoctocog alfa for hemophilia A: results from a phase 1 repeat-dose study. Blood Adv. 2022;6(4):1089\u201394.","journal-title":"Blood Adv"},{"issue":"Suppl 1","key":"1866_CR21","doi-asserted-by":"publisher","first-page":"1035","DOI":"10.1182\/blood-2021-148534","volume":"138","author":"JM Staber","year":"2021","unstructured":"Staber JM, Lissitchkov T, Konkle BA, et al. Efanesoctocog alfa half-life and clearance are independent of von Willebrand factor in severe hemophilia A: a post hoc analysis from phase 1\/2a studies [abstract no. 1035]. Blood. 2021;138(Suppl 1):1035.","journal-title":"Blood"},{"issue":"4","key":"1866_CR22","doi-asserted-by":"publisher","first-page":"310","DOI":"10.1056\/NEJMoa2209226","volume":"388","author":"A von Drygalski","year":"2023","unstructured":"von Drygalski A, Chowdary P, Kulkarni R, et al. Efanesoctocog alfa prophylaxis for patients with severe hemophilia A. N Engl J Med. 2023;388(4):310\u20138.","journal-title":"N Engl J Med"},{"key":"1866_CR23","unstructured":"Swedish Orphan Biovitrum AB. Positive topline results from pivotal XTEND-Kids phase 3 study of efanesoctocog alfa in children under 12 years of age with haemophilia A [media release]. 2 Mar 2023. https:\/\/www.sobi.com\/."}],"updated-by":[{"DOI":"10.1007\/s40265-023-01901-9","type":"correction","label":"Correction","source":"publisher","updated":{"date-parts":[[2023,6,3]],"date-time":"2023-06-03T00:00:00Z","timestamp":1685750400000}}],"container-title":["Drugs"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40265-023-01866-9.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s40265-023-01866-9\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40265-023-01866-9.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,6,3]],"date-time":"2023-06-03T02:27:23Z","timestamp":1685759243000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s40265-023-01866-9"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,4,6]]},"references-count":23,"journal-issue":{"issue":"7","published-print":{"date-parts":[[2023,5]]}},"alternative-id":["1866"],"URL":"https:\/\/doi.org\/10.1007\/s40265-023-01866-9","relation":{},"ISSN":["0012-6667","1179-1950"],"issn-type":[{"value":"0012-6667","type":"print"},{"value":"1179-1950","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,4,6]]},"assertion":[{"value":"6 April 2023","order":1,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"3 June 2023","order":2,"name":"change_date","label":"Change Date","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"Correction","order":3,"name":"change_type","label":"Change Type","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"A Correction to this paper has been published:","order":4,"name":"change_details","label":"Change Details","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"https:\/\/doi.org\/10.1007\/s40265-023-01901-9","URL":"https:\/\/doi.org\/10.1007\/s40265-023-01901-9","order":5,"name":"change_details","label":"Change Details","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The preparation of this review was not supported by any external funding.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Susan J. Keam is a contracted employee of Adis International Ltd\/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Authorship and Conflict of interest"}},{"value":"Not applicable.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability"}}]}}