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AZ, '사프넬로' "마침내" 전신홍반루푸스 FDA 승인 - 바이오스펙테이터

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AZ, '사프넬로' "마침내" 전신홍반루푸스 FDA 승인

입력 2021-08-04 14:12 수정 2021-08-04 15:20

바이오스펙테이터 서일 기자

이 기사는 '프리미엄 뉴스서비스 BioS+' 기사입니다.
1형 인터페론 수용체 항체 최초 허가, 10년간 없던 SLE 신약..중등도에서 중증 환자 표준치료 병용, 3상서 위약 대비 높은 증상 개선 비율 확인

▲아스트라제네카 연구개발 센터(아스트라제네카 웹사이트)

아스트라제네카(AstraZeneca, AZ)의 '사프넬로(Saphnelo, anifrolumab)'가 미국 식품의약국(FDA)으로부터 전신홍반루푸스(systemic lupus erythematosus, SLE) 치료제로 시판 허가를 받았다. 10년만에 새롭게 등장하는 SLE 신약 치료제다.

AZ는 지난 2일(현지시간) 미국 FDA로부터 중등도에서 중증(moderate to severe) SLE 환자에게 표준치료와 병용으로 1형 인터페론 항체 사프넬로(Saphnelo, anifrolumab)의 신약 승인을 받았다고 밝혔다.

표준치료는 경구 코르티코스테로이드(oral corticosteroid, OCS), 항말라리아제(antimalarials), 면역억제제(immunosuppressants) 중 하나 이상을 포함한다. 여기서 면역억제제는 메토트렉세이트(methotrexate), 아자티오프린(azathioprine) 또는 MMF(mycophenolate mofetil)다.

AZ는 사프넬로가 최초로 허가된 1형 인터페론 수용체 길항제이자 해당 적응증에서 10년간 허가된 적이 없는 새로운 SLE 치료제라고 설명했다. 현재 미국 FDA에서 시판 허가 받은 SLE 치료제는 지난 2011년 승인된 GSK(GlaxoSmithKline)의 ‘벤리스타(Benlysta, belimumab)’가 있다. 벤리스타는 B세포 분화 및 증식, 활성화에 관여하는 BLyS(B-lymphocyte stimulator)에 결합해 저해하는 단일클론 항체다....

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