Difference between revisions of "Efanesoctocog alfa (Altuviiio)"
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(Created page with "==Mechanism of action== ==Preliminary data== #'''XTEND-1:''' von Drygalski A, Chowdary P, Kulkarni R, Susen S, Konkle BA, Oldenburg J, Matino D, Klamroth R, Weyand AC, Jimene...") |
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==Mechanism of action== | ==Mechanism of action== | ||
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| + | ==Diseases for which it is used== | ||
| + | *[[Inherited coagulopathy|Congenital hemophilia A]] | ||
==Preliminary data== | ==Preliminary data== | ||
#'''XTEND-1:''' von Drygalski A, Chowdary P, Kulkarni R, Susen S, Konkle BA, Oldenburg J, Matino D, Klamroth R, Weyand AC, Jimenez-Yuste V, Nogami K, Poloskey S, Winding B, Willemze A, Knobe K; XTEND-1 Trial Group. Efanesoctocog Alfa Prophylaxis for Patients with Severe Hemophilia A. N Engl J Med. 2023 Jan 26;388(4):310-318. [https://doi.org/10.1056/nejmoa2209226 link to original article] [https://pubmed.ncbi.nlm.nih.gov/36720133/ PubMed] [https://clinicaltrials.gov/study/NCT04161495 NCT04161495] | #'''XTEND-1:''' von Drygalski A, Chowdary P, Kulkarni R, Susen S, Konkle BA, Oldenburg J, Matino D, Klamroth R, Weyand AC, Jimenez-Yuste V, Nogami K, Poloskey S, Winding B, Willemze A, Knobe K; XTEND-1 Trial Group. Efanesoctocog Alfa Prophylaxis for Patients with Severe Hemophilia A. N Engl J Med. 2023 Jan 26;388(4):310-318. [https://doi.org/10.1056/nejmoa2209226 link to original article] [https://pubmed.ncbi.nlm.nih.gov/36720133/ PubMed] [https://clinicaltrials.gov/study/NCT04161495 NCT04161495] | ||
#'''XTEND-Kids:''' Malec L, Peyvandi F, Chan AKC, Königs C, Zulfikar B, Yuan H, Simpson M, Álvarez Román MT, Carcao M, Staber JM, Dunn AL, Chou SC, d'Oiron R, Albisetti M, Demissie M, Santagostino E, Yarramaneni A, Wong N, Abad-Franch L, Gunawardena S, Fijnvandraat K; XTEND-Kids Trial Group. Efanesoctocog Alfa Prophylaxis for Children with Severe Hemophilia A. N Engl J Med. 2024 Jul 18;391(3):235-246. [https://doi.org/10.1056/nejmoa2312611 link to original article] [https://pubmed.ncbi.nlm.nih.gov/39018533/ PubMed] [https://clinicaltrials.gov/study/NCT04759131 NCT04759131] | #'''XTEND-Kids:''' Malec L, Peyvandi F, Chan AKC, Königs C, Zulfikar B, Yuan H, Simpson M, Álvarez Román MT, Carcao M, Staber JM, Dunn AL, Chou SC, d'Oiron R, Albisetti M, Demissie M, Santagostino E, Yarramaneni A, Wong N, Abad-Franch L, Gunawardena S, Fijnvandraat K; XTEND-Kids Trial Group. Efanesoctocog Alfa Prophylaxis for Children with Severe Hemophilia A. N Engl J Med. 2024 Jul 18;391(3):235-246. [https://doi.org/10.1056/nejmoa2312611 link to original article] [https://pubmed.ncbi.nlm.nih.gov/39018533/ PubMed] [https://clinicaltrials.gov/study/NCT04759131 NCT04759131] | ||
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| + | ==History of changes in FDA indication== | ||
| + | *2023-02-22: Initial approval for use in adults and children with Hemophilia A (congenital Factor VIII deficiency) for: (1) Routine prophylaxis to reduce the frequency of bleeding episodes; (2) On-demand treatment and control of bleeding episodes; and (3) Perioperative management of bleeding. ''(Based on XTEND-1)'' | ||
| + | *2024-05-10: Approval updated to include additional evidence. ''(Based on XTEND-Kids)'' | ||
| + | |||
| + | ==Also known as== | ||
| + | *'''Code name:''' BIVV-001 | ||
| + | *'''Brand name:''' Altuviiio | ||
[[Category:Drugs]] | [[Category:Drugs]] | ||
| − | [[Category: | + | [[Category:Inherited coagulopathy medications]] |
[[Category:Stub]] | [[Category:Stub]] | ||
Latest revision as of 15:37, 18 July 2024
Mechanism of action
Diseases for which it is used
Preliminary data
- XTEND-1: von Drygalski A, Chowdary P, Kulkarni R, Susen S, Konkle BA, Oldenburg J, Matino D, Klamroth R, Weyand AC, Jimenez-Yuste V, Nogami K, Poloskey S, Winding B, Willemze A, Knobe K; XTEND-1 Trial Group. Efanesoctocog Alfa Prophylaxis for Patients with Severe Hemophilia A. N Engl J Med. 2023 Jan 26;388(4):310-318. link to original article PubMed NCT04161495
- XTEND-Kids: Malec L, Peyvandi F, Chan AKC, Königs C, Zulfikar B, Yuan H, Simpson M, Álvarez Román MT, Carcao M, Staber JM, Dunn AL, Chou SC, d'Oiron R, Albisetti M, Demissie M, Santagostino E, Yarramaneni A, Wong N, Abad-Franch L, Gunawardena S, Fijnvandraat K; XTEND-Kids Trial Group. Efanesoctocog Alfa Prophylaxis for Children with Severe Hemophilia A. N Engl J Med. 2024 Jul 18;391(3):235-246. link to original article PubMed NCT04759131
History of changes in FDA indication
- 2023-02-22: Initial approval for use in adults and children with Hemophilia A (congenital Factor VIII deficiency) for: (1) Routine prophylaxis to reduce the frequency of bleeding episodes; (2) On-demand treatment and control of bleeding episodes; and (3) Perioperative management of bleeding. (Based on XTEND-1)
- 2024-05-10: Approval updated to include additional evidence. (Based on XTEND-Kids)
Also known as
- Code name: BIVV-001
- Brand name: Altuviiio