FDA approval of bedaquiline - The benefit-risk balance for drug-resistant tuberculosis

New England Journal of Medicine

Volumn 371, Issue 8, 2014, Pages 689-691

  Cox, Edward ^a   Laessig, Katherine ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BEDAQUILINE; CYCLOSERINE; ETHAMBUTOL; KANAMYCIN; OFLOXACIN; PLACEBO; PYRAZINAMIDE; TERIZIDONE;

CAUSE OF DEATH; DISEASE COURSE; DRUG APPROVAL; DRUG EFFICACY; DRUG FATALITY; DRUG INDICATION; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HIGH RISK POPULATION; HUMAN; INCIDENCE; MORTALITY; MULTIDRUG RESISTANT TUBERCULOSIS; PHASE 2 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RISK BENEFIT ANALYSIS; SHORT SURVEY; SURVIVAL RATE; TREATMENT OUTCOME;

ANTITUBERCULAR AGENTS; DIARYLQUINOLINES; FEMALE; HUMANS; MALE; MYCOBACTERIUM TUBERCULOSIS; TUBERCULOSIS, MULTIDRUG-RESISTANT;

EID: 84907302558     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMp1314385     Document Type: Article

References (5)

1. Sirturo (bedaquiline) product insert. Silver Spring, MD: Food and Drug Administration (http://www.accessdata.fda.gov/drugsatfda-docs/label/2012/ 204384s000lbl.pdf).
2. Avorn J. Approval of a tuberculosis drug based on a paradoxical surrogate measure. JAMA 2013;309:1349-50.
3. Global tuberculosis report 2013. Geneva: World Health Organization, 2013 (http://apps.who.int/iris/bitstream/10665/91355/1/9789241564656-eng.pdf).
4. Tiemersma EW, van der Werf MJ, Borgdorff MW, Williams BG, Nagelkerke NJ. Natural history of tuberculosis: duration and fatality of untreated pulmonary tuberculosis in HIV negative patients: a systematic review. PLoS One 2011;6(4):e17601.
5. Center for Drug Evaluation and Research. Medical officer review: Sirturo (bedaquiline). Silver Spring, MD: Food and Drug Administration (http://www.accessdata.fda.gov/drugsatfda-docs/nda/2012/204384Orig1s000MedR-. pdf).