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아스트라제네카, 신약우선심사권(PRV) 9500만弗에 매입 - 바이오스펙테이터

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아스트라제네카, 신약우선심사권(PRV) 9500만弗에 매입

입력 2019-08-23 17:09 수정 2019-08-27 13:13

바이오스펙테이터 봉나은 기자

이 기사는 '프리미엄 뉴스서비스 BioS+' 기사입니다.
스위스 제약사 소비(Sobi)의 PRV 매입.."신성빈혈 치료제 후보물질 ‘록사두스타트’나 HER2 타깃 ADC 항암 후보물질 ‘DS-8201’에 PRV 적용할 것으로 예측"

아스트라제네카(AstraZeneca)는 스위스 제약사 소비(Swedish Orphan Biovitrum AB, Sobi)로부터 미국 식품의약국(FDA)의 신약 허가 우선심사권(Priority Review Voucher, PRV)을 현금 9500만달러에 매입하는 계약을 맺었다고 22일(현지시간) 발표했다.

소비는 지난 6월 노브이뮨(Novimmune)으로부터 원발성 혈구탐식성 림프조직구증(Primary Haemophagocytic lymphohistiocytosis, HLH) 치료제로 승인받은 ‘가미판트(Gamifant, 성분명: emapalumab)’에 대한 모든 자산을 인수함에 따라 PRV를 획득했다.

FDA는 소아 희귀질환 및 난치성 질환 치료제를 승인받은 기업에 인센티브와 같은 개념의 PRV를 제공한다. PRV는 신약 허가 신청에 대한 비용 절감, 단축된 검토 기간을 보장함으로써 기업이 또 다른 희귀질환 치료제 개발에 기여할 수 있도록 돕는 역할을 한다. PRV를 적용한 제품은 기존 10개월에서 4개월이 단축된 6개월의 검토기간 동안 신속하게 신약 승인을 심사받을 수 있게된다.

이에 따라 PRV는, 경쟁이 치열하고 선점기업이 우위를 차지할 수 있는 치료제 시장의 후보물질에 주로 사용되고 있다. 특히 PRV는 판매가 가능하다는 점을 이용해 소규모 제약사가 글로벌 규모의 제약사와 PRV를 거래하는 경우가 종종 있다....

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