Warning: mysql_real_escape_string(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_real_escape_string(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_query(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_query(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_num_rows() expects parameter 1 to be resource, boolean given in /service/web/biospcmbl/comlib/dblib.php on line 348

Warning: mysql_real_escape_string(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_real_escape_string(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_query(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_query(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_num_rows() expects parameter 1 to be resource, boolean given in /service/web/biospcmbl/comlib/dblib.php on line 348

Warning: mysql_real_escape_string(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_real_escape_string(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_query(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_query(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_num_rows() expects parameter 1 to be resource, boolean given in /service/web/biospcmbl/comlib/dblib.php on line 348

Warning: mysql_real_escape_string(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_real_escape_string(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_query(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_query(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_num_rows() expects parameter 1 to be resource, boolean given in /service/web/biospcmbl/comlib/dblib.php on line 348

Warning: mysql_real_escape_string(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_real_escape_string(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_query(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_query(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_num_rows() expects parameter 1 to be resource, boolean given in /service/web/biospcmbl/comlib/dblib.php on line 348

Warning: mysql_real_escape_string(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_real_escape_string(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_query(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_query(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_num_rows() expects parameter 1 to be resource, boolean given in /service/web/biospcmbl/comlib/dblib.php on line 348

Warning: mysql_real_escape_string(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_real_escape_string(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_query(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_query(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_num_rows() expects parameter 1 to be resource, boolean given in /service/web/biospcmbl/comlib/dblib.php on line 348

Warning: mysql_real_escape_string(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_real_escape_string(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_query(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_query(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_num_rows() expects parameter 1 to be resource, boolean given in /service/web/biospcmbl/comlib/dblib.php on line 348

Warning: mysql_real_escape_string(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_real_escape_string(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_query(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_query(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_num_rows() expects parameter 1 to be resource, boolean given in /service/web/biospcmbl/comlib/dblib.php on line 348

Warning: mysql_real_escape_string(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_real_escape_string(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_query(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_query(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 346

Warning: mysql_num_rows() expects parameter 1 to be resource, boolean given in /service/web/biospcmbl/comlib/dblib.php on line 348

Warning: mysql_real_escape_string(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_real_escape_string(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 30

Warning: mysql_query(): Access denied for user 'biosssh118'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 530

Warning: mysql_query(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 530

Warning: mysql_fetch_array() expects parameter 1 to be resource, boolean given in /service/web/biospcmbl/comlib/dblib.php on line 531
나브리바, 단백질 합성 저해 항생제 '젠레타' FDA 승인 - 바이오스펙테이터

본문 바로가기

바이오스펙테이터

기사본문

나브리바, 단백질 합성 저해 항생제 '젠레타' FDA 승인

입력 2019-08-21 07:09 수정 2019-08-23 12:16

바이오스펙테이터 이승환 기자

플류로무틸린 계열 항생제 ‘젠레타’..지역사회획득성폐렴(CABP) 환자 대상 사용..임상3상에서 기존 항생제 목시플록사신 수준의 효능 확인

감염질환 치료제를 개발하는 아일랜드 나브리바 테라퓨틱스(Nabriva Therapeutics)의 ‘젠레타(Xenleta, 성분명 lefamulin)’가 19일(현지시간) 미국 식품의약국(FDA)으로부터 신약판매 승인을 받았다.

플류로무틸린(pleuromutilins) 계열 항생제인 젠레타는 폐렴 연쇄상구균(Streptococcus pneumoniae)의 리보솜 S50(ribosome S50)의 A자리, P자리, 펩타이드 전이효소(peptidyl transferase)에 결합해 단백질 합성을 억제하는 것으로 병원균의 증식을 막는다. 정맥주사형, 경구형으로 판매될 예정인 젠레타는 18세 이상의 지역사회획득성폐렴(community-acquired bacterial pneumonia, CABP) 환자에 12시간마다 1번씩 단독요법으로 투여한다.

폐렴 연쇄상구균 외에 젠레타 사용이 가능한 균주로는 메티실린 감수성 황색포도상구균(methicillin-susceptible Staphylococcus aureus, MSSA), 헤모필루스 인플루엔자균(Haemophilus influenzae), 레지오넬라 뉴모필라(Legionella pneumophila), 폐렴미코플라스마(Mycoplasma pneumoniae), 폐렴 클라미디아(Chlamydophila pneumoniae)다.

FDA 승인의 근거가 된 2건의 임상3상(LEAP1, NCT02559310; LEAP2, NCT02813694)에서 젠레타는 기존 항생제인 목시플록사신(moxifloxacin), 리네졸리드(linezolid) 수준의 효능을 보였다. LEAP1 연구에선 정맥주사형, 경구형 젠레타를 사용했으며, LEAP2 연구에선 경구형 젠레타를 사용했다. 젠레타 임상시험에서 비교 대상으로 사용된 목시플록사신은 병원균의 DNA 회전효소 II, IV에 결합해 DNA 복제를 억제하는 것으로 증식을 막으며, 리네졸리드는 병원균의 리보솜 S70에 결합해 증식을 막는다. 젠레타와 기존 항생제의 비교는 목시플록사신을 기준으로 진행했으며, 리네졸리드는 환자의 상태에 따라 목시플록사신과의 병용요법으로 투여됐다.

LEAP1 연구에서 초기임상반응률(early clinical response, ECR)은 젠레타 87.3%, 목시플록사신 90.2%로 나타났다. LEAP2 연구의 초기임상반응률은 젠레타 90.8%, 목시플록사신 90.8%로 확인됐다. 주요 부작용으로는 설사, 구역질, 간 효소 수치 상승 등이 발견됐다. 나브리바는 임상시험과정에서 젠레타가 CYP3A4(cytochrome P450 3A4)와의 약물 대사과정 부작용으로 환자의 심전도 QT 간격이 길어지는 것을 확인했으며, 이는 심실부정맥을 유발할 수 있기에 주의가 필요하다고 밝혔다.

한편, FDA는 지난 4월 나브리바의 ‘콘테포(Contepo, 성분명 fosfomycin)’ 신약허가신청(New Drug Application, NDA)에 대한 승인을 보류하며, 최종보완요구공문(Complete Response Letter, CRL)을 요청한 바 있다. 급성 신우염(acute pyelonephritis) 환자를 포함해 복잡성요로감염증(complicated urinary tract infections, cUTI) 환자를 대상으로 임상시험을 진행한 콘테포는 정맥주사제로 만든 포스포마이신(fosfomycin)이다. FDA가 새로운 임상시험 결과를 요구하거나, 염려되는 부작용 문제를 언급하지 않았다고 나브리바는 밝혔다.

카카오스토리로 기사 공유하기