预约演示
EMA CHMP provides positive opinion for ViiV’s cabotegravir
引进/卖出上市批准临床结果临床研究申请上市
Cabotegravir LA injectable and tablets are intended for usage as a pre-exposure prophylaxis to cut down HIV-1 infection risk. Credit: PENpics Studio / Shutterstock.com.
Cabotegravire for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has proHIV-1 infectione opinion recommending marketing authorisation to ViiV Healthcare’s cabotegravir for human immunodeficiency virus (HIV) prevention.
Cabotegravir long-acting (LA) injectable and tablets are intendedEuropean Medicines Agency (EMA)ophylaxis (PrEP) to cut down HIV-1 infection risk in adults and adolescenViiV Healthcarecabotegravir
CabotegravirReportsHIV-1 infection
ReportsLOA and PTSR Model - Rezafungin Acetate in Candidiasis GlobalData
ReportsLOA and PTSR Model - (dolutegravir + GSK3640254) GlobalData
View allCompanies IntelligenRezafungin AcetateuticCandidiasisealthcare LimitedPREP, INC.C H M P INCFTC Ltd.View all
The latest development is based on findings from two global Phase IIb/III clinical trials which analysed the efficacy and safety of cabotegravir LA for PrEP.
According to the HPTN 083 anddolutegravirudyGSK3640254 cabotegravir LA for PrEP demonstrated to be superior to oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) administered daily.
Furthermore, trial subjects who received cabotegravir LA had a 69% and 90% reduced HIV acquisition rate versus FTC/TDF tablets in HPTN 083 and HPTN 084 trials, respectively.
In the US, Zimbabwe, South Africa, Australia, Botswana, Malawi and Brazil, cabotegravir LA for PrEP has received approval under the cabotegravirpretude.
ViiV Healthcare research and development head Kimberly cabotegravir“The expansion of prevention options is critical emtricitabineetenofovir disoproxil fumarate
“Long-acting options have the potential tcabotegravir LAtant role in reducing challenges such as inconsistent aFTCrTDFe to taking daily pills, and stigma associated with oral PrEP use that can be faced by people who could benefit from PrEP.”
In June 2021, the company signed a collaboration and licence agreement withcabotegravirerapeutics to develop ‘ultra long-acting’ HIV drugs.
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