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말린크로트, HRS-1 치료제 ‘텔리프레신’ FDA 승인거절 - 바이오스펙테이터

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말린크로트, HRS-1 치료제 ‘텔리프레신’ FDA 승인거절

입력 2020-09-16 13:30 수정 2020-09-16 13:30

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HRS-1 치료제 ‘텔리프레신’, 지난 7월 자문위 승인권고 불구 ‘승인거절’..말린크로트, “FDA 승인 받기 위한 모든 노력 할 것”

말린크로트 파마슈티컬스(Mallinckrodt Pharmaceuticals)의 1형 간신증후군(Hepatorenal Syndrome Type 1, HRS-1)치료제 '텔리프레신(terlipressin)'에 대한 미국식품의약국(FDA)의 판매 승인이 거절됐다. 지난 7월 자문위원회는 텔리프레신에 대해 승인 권고 입장을 밝혔지만, FDA는 논의가 더 필요하다는 입장을 취한 것이다.

말린크로트는 지난 14일(현지시간) 미국 FDA로부터 '텔리프레신(terlipressin)' 승인 관련 보안요청서한(Complete Response Letter, CRL)을 받았다고 밝혔다. CRL에는 텔리프레신에 대한 NDA 승인이 거절됐고, HRS-1환자에 대해 텔리프레신의 긍정적인 위해성-유익성 프로파일(risk-benefit profile) 데이터가 요구된다는 내용이 포함됐다. 이는 텔리프레신이 가진 잠재적 유익성이 위해성보다 더 커야하고, 말린크로트는 이를 뒷받침할 수 있는 데이터를 FDA에 추가로 제출해야 한다는 의미다.

지난 7월 FDA의 심혈관, 신장의약품 자문위원회(Cardiovascular and Renal Drugs Advisory Committee, CRDAC)는 텔리프레신에 대한 FDA 승인을 권고했다(찬성 8표, 반대 7표). 이때 FDA는 자문위원회에 임상결과가 HRS-1의 치료효과를 반영하는지에 대한 논의가 필요하다고 밝힌 바 있었다.

텔리프레신은 V1 receptor에 선택적으로 작용하는 바소프레신 유사체(vasopressin analogue)이다.

말린크로트는 임상3상에서 300명의 HRS-1 환자를 대상으로 임상을 진행했다. VHRSR(Verified HRS Reversal)을 달성한 환자는 텔리프레신 투약군에서 29.1%, 위약군에서 15.8% 였다(p=0.012). VHRSR은 15일 동안 최소 2시간 간격, 2회 연속 혈청 크레아틴 농도가 1.5mg/dL 이하이고, 신기능대치요법(Renal Replacement Therapy, RRT) 없이 최소 10일동안 생존함을 의미한다. 이 결과로 임상 3상의 1차종결점을 충족시켰다.

1형 간신증후군(Hepatorenal Syndrome Type 1, HRS-1)은 간기능장애와 문맥압항진증 환자에게서 신기능저하가 나타나는 질병으로, 미국에서 연 3만5000명정도의 HRS-1환자가 발생한다. HRS-1은 생존기간 중간값이 약 2주, 3개월 후에는 환자의 80%가 사망에 이르는 예후가 좋지 않은 질병이다.

스티븐 로마노(Stenen Romano) 말린크로트 부사장겸 CSO(Chief Scientific Officer)는 “텔리프레신에 대한 FDA의 승인거절로 실망했지만 희귀조건에서 진행한 큰 규모의 임상은 힘을 가진다”며, “아직 HRS-1에 대해 FDA 승인받은 치료제가 없다”고 말했다. 그는 이어 “텔리프레신의 FDA 승인을 위해 모든 노력을 할 것”이라고 밝혔다.

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