FDA accepts new drug application from Roche Hemlibra ® (emicizumab-kxwh)
-
Last Update: 2020-06-11
-
Source: Internet
-
Author: User
Search more information of high quality chemicals, good prices and reliable suppliers, visit
www.echemi.com
recentdays, RochePharmaceutical(announced that the U.SFDA(which has accepted the Hemlibra ® (emicizumab-kxwh) for the treatment of adults and children with no type 8 factor inhibitor, hemophilia,new drug(application (sBLA) and granted it priority reviewrelated studies
in THE HAVEN 3 study, haemorrhagic adults and adolescents aged 12 and over who received Hemlibra prevention weekly or every two weeks had a 96% reduction in bleeding (p 0.0001) and 97% (p 00001) and 97% (p 00001)in another subgroup, the study was that patients who had received The Factor VIII prevention in non-interventional studies were now able to use Hemlibra in the two-disordered groupBased on internal patient comparisons, Hemlibra's post-treatment bleeding decreased by 68% (p0.0001), becoming the first treatment to be better than previous standarddrug(treatment)adverse events
No serious adverse events (AEs) associated with Hemlibra were found in 3 HAVEN studies, and the most common AEs were consistent with previous studiesThe most common AEs in 5% or more of the study were injection site reactions, joint pain (joint pain), common cold symptoms (nasopharyngitis), headache, upper respiratory tract infections, and influenza
This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only.
This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of
the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed
description of the concern or complaint, to
service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content
will be removed immediately.
