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비브, '한달에 한번' HIV-1 주사제 "유럽 판매허가" - 바이오스펙테이터

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비브, '한달에 한번' HIV-1 주사제 "유럽 판매허가"

입력 2020-12-29 09:51 수정 2021-01-29 17:40

바이오스펙테이터 서일 기자

이 기사는 '프리미엄 뉴스서비스 BioS+' 기사입니다.
'보카브리아’ + 얀센 '레캄비스’ 병용투여 허가.. 월 1회 주사 만으로 HIV-1 감염 억제 효과 장기 지속

GSK(GlaxoSmithKline)와 화이자(Pfizer)가 설립한 HIV 치료제 전문회사 비브 헬스케어(ViiV Healthcare)가 장기지속형 HIV-1 치료 주사제를 유럽에 시판한다. 한달에 한번 혹은 두달에 한번 주사하는 치료제로 기존에 경구용 항바이러스제를 매일 복용해야 하는 HIV 환자의 부담을 덜 수 었을 것으로 보인다.

GSK는 지난 21일(현지시간) 비브 헬스케어가 유럽연합 집행위원회(European Commission, EC)로부터 HIV-1 치료제 '보카브리아(cabotegravir injection, tablets)'와 얀센(Janssen)의 HIV-1 치료제 레캄비스(Rekambys, rilpivirine injection) 혹은 에듀란트(Edurant, rilpivirine tablets)의 병용요법에 대한 판매허가(Marketing Authorization)를 받았다고 발표했다.

보카브리아의 판매허가는 비브가 16개국 1200명 이상의 HIV-1 환자를 대상으로 진행한 주요 임상 3상 ATLAS (Antiretroviral Therapy as Long-Acting Suppression), FLAIR (First Long-Acting Injectable Regimen), 그리고 ATLAS-2M 임상 결과에 기반했다.

ATLAS 3상에서 보카브리아와 에듀란트 혹은 레캄비스의 병용투여는 기존 경구용 항레트로바이러스 치료제와 대비하여 HIV 바이러스 억제 효능에서 비열등성을 보였다....

'프리미엄 뉴스서비스 BioS+'는 독자들에게 가치(value)있는 기사를 제공합니다.
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