FDA approves ADMA's application for listing of intravenous immunoglobulin 10% formulation Asceniv
-
Last Update: 2020-06-10
-
Source: Internet
-
Author: User
Search more information of high quality chemicals, good prices and reliable suppliers, visit
www.echemi.com
PIDD refers to the loss of some function or disorder of the body's immune system due to genetic causesGiven the loss of part of the immune system, people with PIDD are more susceptible to infection and the recovery process after infection is slowerrecently, ADMA BiologyMedicines(http://Company
(http:// announcedthat theFDA(http://approved the listing of its new intravenous immunoglobulin (HTTP://WWW.CHEMDRUG.COM/ARTICLE/11/) 10% formulation, Asceniv (formerly RI-002), for the treatment of primary immunodeficiency (PIDD) adolescents (12 to 17 years old) and adult patientsThenew drug(http:// is expected to meet patients in the second half of 2019RI-002 is an OVIG purified fromHealth(http://donated plasma by individuals, containing naturally occurring multi-clone antibodies from donor plasma, as well as high levels of neutralizing antibodies against respiratory syncytial virus (RSV)The approval of this listing application is based on positive data from theTest(http://The trial reached its main endpoint, the incidence of severe bacterial infection (Serious Bacterial Infections, SBI)results showed that no SBI occurred in PID patients within 12 monthsSecondary endpoints include the first SBI occurrence and the first serious infection, the number of days antibiotics are used, the number of days you need to stop and stop working, the type of infection, and the chance of hospitalization
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.
