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셀트리온, '램시마SC' 3상 결과 韓·中·日에 소개 - 바이오스펙테이터

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셀트리온, '램시마SC' 3상 결과 韓·中·日에 소개

입력 2019-09-08 09:36 수정 2019-09-09 06:42

바이오스펙테이터 장종원 기자

동아시아류마티스학회서 1·3상 결과 발표"하반기 유럽 판매 승인에 역량 집중"

셀트리온이 자가면역질환 바이오의약품 '램시마(인플릭시맙) 피하주사(SC)'의 임상 3상 결과를 국내와 동아시아 의료진에게 소개하며 학술마케팅에 나섰다. 셀트리온은 작년 12월 유럽의약품청(EMA)에 램시마SC 허가를 신청해 올해 하반기 심사결과가 나올 것으로 기대하고 있다.

셀트리온은 6~7일 삼성동 그랜드 인터컨티넨탈 서울 파르나스에서 열린 동아시아 류마티스 학회(EAGOR, East Asian Group of Rheumatology)에서 국내외 의료진을 대상으로 램시마SC의 임상 1∙3상 결과를 발표했다.

램시마SC의 임상 1∙3상 파트2 결과는 최초의 제형 변경 인플릭시맙 제제인 램시마SC의 효능 및 안전성에 대한 종합 임상 결과를 담고 있다.

류마티스관절염 환자 357명 대상으로 한 임상 결과 투여 30주차까지 램시마SC와 램시마(정맥주사제형 IV) 투여군 간 유사한 안전성 결과가 나타났으며, 효과면에서도 DAS28(CRP)의 두 군 간 평균 값 차이를 통해 램시마에 대한 램시마SC의 비열등성이 입증됐다. 또한 류마티스관절염 치료반응평가 지표인 ACR 반응률 및 EULAR 반응률에서 모두 램시마SC 투여군에서 램시마 투여군 대비 높은 효과가 확인됐다

연자로 나선 유대현 한양대학교 류마티스병원 교수는 "램시마SC를 처방한 환자군의 약물 유효성과 안전성 등을 평가한 결과 기존 램시마와 비교해 동등성을 확인했다"면서 "램시마SC가 류마티스관절염 등 자가면역질환 환자의 치료 편의성을 높이는 또 다른 처방 수단이 될 수 있음을 확인했다"고 말했다.

셀트리온은 램시마SC를 향후 주력 제품으로 삼아 하반기 유럽 허가를 위한 가능한 모든 역량을 집중할 방침이다. 램시마SC가 승인 받게 되면 인플릭시맙 성분 시장 최초의 피하주사 제형(SC) 의약품으로 등재된다.

셀트리온 임상개발본부의 이상준 수석부사장은 "국내외 학회에서의 잇따른 임상결과 발표를 통해 램시마SC의 성공 가능성을 확인했다"며 "램시마SC는 의료계의 니즈를 바탕으로 개발을 시작하게 됐으며 피하주사 제형으로 환자 편의성을 크게 개선하는 장점과 동시에 우수한 안전성과 효과까지 임상결과를 통해 입증된 만큼 충분한 글로벌 경쟁력을 갖춘 램시마SC를 글로벌 블록버스터 제품으로 육성할 것"이라고 말했다.

한편 동아시아 류마티스 학회(EAGOR)는 한국, 일본, 중국, 대만, 홍콩 등 아시아권 전문의 300여 명과 의료계 전문가들이 참여하는 아시아 최고 권위의 류마티스 학회다.

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