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F r o m W i k i p e d i a , t h e f r e e e n c y c l o p e d i a
Emicizumab , sold under the brand name Hemlibra , is a humanized bispecific monoclonal antibody for the treatment of haemophilia A , developed by Genentech and Chugai (both organizations are subsidiaries of Hoffmann-La Roche ).[4] clinical trial found that it was well tolerated by healthy subjects.[5]
In November 2017, it was approved in the United States for treatment of haemophilia A in those who had developed resistance to other treatments.[6] breakthrough therapy designation for treatment of haemophila A in those who have not developed resistance to other treatments.[7] Food and Drug Administration (FDA) considers it to be a first-in-class medication .[8]
Studies indicate that emicizumab is a better therapy compared to the previous generations, due to subcutaneous administration and fewer injections, which reduces injection site reactions and makes therapy less troublesome.[9]
Adverse effects [ edit ]
The most common adverse reactions (incidence ≥10%) are injection site reactions , headache , and arthralgia .[10]
Mechanism of action [ edit ]
Emicizumab binds to both the activated coagulation factor IX and to factor X , mediating the activation of the latter. This is normally the function of coagulation factor VIII , which is missing in haemophilia A patients.[4] [11]
See also [ edit ]
References [ edit ]
^ "Summary Basis of Decision (SBD) for Hemlibra" . Health Canada . Retrieved 29 May 2022 .
^ a b Spreitzer H (4 July 2016). "Neue Wirkstoffe - Emicizumab". Österreichische Apothekerzeitung (in German) (14/2016).
^ Uchida N, Sambe T, Yoneyama K, Fukazawa N, Kawanishi T, Kobayashi S, et al. (March 2016). "A first-in-human phase 1 study of ACE910, a novel factor VIII-mimetic bispecific antibody, in healthy subjects" . Blood . 127 (13 ): 1633–41. doi :10.1182/blood-2015-06-650226 . PMC 4817308 PMID 26626991 .
^ "Roche hemophilia drug wins FDA nod, with a warning" . Reuters. 17 November 2017.
^ "FDA Grants Roche Breakthrough Therapy Designation on Hemophilia Drug" . BioPharm International . UBM. 19 April 2018. Retrieved 20 April 2018 .
^ New Drug Therapy Approvals 2017 (PDF) . U.S. Food and Drug Administration (FDA) (Report). January 2018. Retrieved 16 September 2020 .
^ Grabowska K, Grzelak M, Zhao LY, Płuciennik E, Pasieka Z, Kciuk M, et al. (May 2024). "Emicizumab as a Promising Form of Therapy for Type A Hemophilia - A Review of Current Knowledge from Clinical Trials". Current Protein & Peptide Science . 25 doi :10.2174/0113892037294674240509094418 . PMID 38797909 .
^ FDA Professional Drug Information
^ Shima M, Hanabusa H, Taki M, Matsushita T, Sato T, Fukutake K, et al. (May 2016). "Factor VIII-Mimetic Function of Humanized Bispecific Antibody in Hemophilia A" . The New England Journal of Medicine . 374 (21 ): 2044–53. doi :10.1056/NEJMoa1511769 PMID 27223146 .
External links [ edit ]
"Emicizumab" . Drug Information Portal . U.S. National Library of Medicine.
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R e t r i e v e d f r o m " https://en.wikipedia.org/w/index.php?title=Emicizumab&oldid=1230789722 " C a t e g o r i e s : ● H a e m o p h i l i a d r u g s ● D r u g s d e v e l o p e d b y H o f f m a n n - L a R o c h e ● D r u g s d e v e l o p e d b y G e n e n t e c h ● M o n o c l o n a l a n t i b o d i e s ● M o n o c l o n a l a n t i b o d y s t u b s ● B l o o d a n d b l o o d f o r m i n g o r g a n d r u g s t u b s H i d d e n c a t e g o r i e s : ● C S 1 G e r m a n - l a n g u a g e s o u r c e s ( de ) ● A r t i c l e s w i t h s h o r t d e s c r i p t i o n ● S h o r t d e s c r i p t i o n i s d i f f e r e n t f r o m W i k i d a t a ● U s e d m y d a t e s f r o m N o v e m b e r 2 0 1 9 ● D r u g s w i t h n o n - s t a n d a r d l e g a l s t a t u s ● C h e m i c a l s t h a t d o n o t h a v e a C h e m S p i d e r I D a s s i g n e d ● A r t i c l e s w i t h o u t E B I s o u r c e ● A r t i c l e s w i t h o u t I n C h I s o u r c e ● A r t i c l e s c o n t a i n i n g u n v e r i f i e d c h e m i c a l i n f o b o x e s ● D r u g s t h a t a r e a m o n o c l o n a l a n t i b o d y ● A l l s t u b a r t i c l e s
● T h i s p a g e w a s l a s t e d i t e d o n 2 4 J u n e 2 0 2 4 , a t 1 8 : 3 9 ( U T C ) . ● T e x t i s a v a i l a b l e u n d e r t h e C r e a t i v e C o m m o n s A t t r i b u t i o n - S h a r e A l i k e L i c e n s e 4 . 0 ;
a d d i t i o n a l t e r m s m a y a p p l y . B y u s i n g t h i s s i t e , y o u a g r e e t o t h e T e r m s o f U s e a n d P r i v a c y P o l i c y . W i k i p e d i a ® i s a r e g i s t e r e d t r a d e m a r k o f t h e W i k i m e d i a F o u n d a t i o n , I n c . , a n o n - p r o f i t o r g a n i z a t i o n . ● P r i v a c y p o l i c y ● A b o u t W i k i p e d i a ● D i s c l a i m e r s ● C o n t a c t W i k i p e d i a ● C o d e o f C o n d u c t ● D e v e l o p e r s ● S t a t i s t i c s ● C o o k i e s t a t e m e n t ● M o b i l e v i e w
