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조제닉스, 소아뇌전증 '드라베증후군' 치료제 FDA 승인 - 바이오스펙테이터

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조제닉스, 소아뇌전증 '드라베증후군' 치료제 FDA 승인

입력 2020-06-29 15:11 수정 2020-06-29 15:11

바이오스펙테이터 서윤석 기자

세로토닌/시그마-1 수용체 동시 활성화 ‘핀테플라’..드라베증후군 환자서 월간발작빈도 50% 이상 감소..오는 7월 출시예정

조제닉스(Zogenix)가 드라베증후군(Dravet syndrome)에 대한 치료제의 판매를 미국 식품의약국(FDA)으로부터 승인받았다. 약물이 시판되면 GW 파마슈티컬스(GW Pharmaceuticals)의 ‘ 에피디올렉스(Epidiolex, cannabidiol)’, 바이오코덱스(Biocodex)의 ‘다이아코밋(Diacomit, stiripentol)과 경쟁하게 된다.

조제닉스는 26일(현지시간) 미국 식품의약국(FDA)에서 드라베증후군과 관련된 발작(seizures)에 대한 치료제로 ‘핀테플라(Fintepla, fenfluramine)’를 승인받았다고 밝혔다. 조제닉스는 오는 7월 핀테플라를 시판할 계획이다.

드라베증후군은 희귀 소아뇌전증으로 발작의 발생빈도가 높으며, 치료제 내성 발작, 심각한 발달장애 및 운동장애 등으로 인해 예상치 못한 사망(sudden unexpected death, SUDEP)의 위험이 높은 질병이다.

현재 드라베증후군을 대상으로 FDA의 승인을 받은 약물은 GW의 카나비디올 수용체 작용제(cannabidiol receptor agonist) ‘에피디올렉스’와 프랑스 바이오코덱스의 ‘다이아코밋’이 있다. 다이아코밋은 p450을 저해하고, 신경전달물질인 GABA의 활성을 증가시키는 기전이다. 핀테플라는 세로토닌 수용체(serotonin receptor)와 시그마-1 수용체(sigma-1 receptor)을 동시에 활성화하는 방식으로 기존 약물들과 다른 기전을 가진다.

FDA는 핀테플라의 효과가 2~18세 사이의 드라베증후군 환자를 대상으로 진행한 임상연구에서 확인됐다고 설명했다. 핀테플라를 투여받은 환자는 위약군보다 월간 발작빈도(monthly convulsive seizure frequency, MCSF)가 위약군 대비 현저히 감소한 것이다. 구체적으로 0.4mg/kg/d 용량의 핀테플라로 치료받은 그룹(43명)은 위약군(44명) 대비 월간발작빈도가 54%(95% CI, 35.6%-67.2%; p<0.001), 7mg/kg/d 용량의 핀테플라로 치료받은 그룹(40명)은 위약군(40명) 대비 62.3%의 월간발작빈도 감소(95% CI 47.7–72.8, p<0.0001) 결과를 나타냈다. 대부분의 환자는 3~4주내에 약효를 나타냈으며, 14~15주간의 치료기간동안 효과가 유지됐다.

가장 흔하게 나타난 이상반응은 식욕감소, 졸음, 진정, 무기력 등이었다.

요셉 설리반(Joseph Sullivan) UCSF 소아뇌전증센터 교수은 “현재 승인받은 항경련증 약물을 복용하는데도 불구하고 심한 발작을 계속 경험하는 드라베증후군 환자에게는 미충족 의료수요가 있다”며 “핀테플라는 경련발작 빈도를 크게 줄이고 지속된 효과를 보이는 만큼 드라베증후군 환자에게 매우 중요한 치료옵션이 될 것”이라고 말했다.

한편, 조제닉스는 희귀 소아뇌전증인 레녹스-가스토 증후군(Lennox-Gastaut syndrome, LGS)에 대한 임상 3상에서 핀테플라가 월간 낙상빈도(drop seizures)를 감소시키며 1차 종결점을 충족시킨 결과를 발표한 바 있다.

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