Forced vital capacity in idiopathic pulmonary fibrosis - FDA review of pirfenidone and nintedanib

New England Journal of Medicine

Volumn 372, Issue 13, 2015, Pages 1189-1191

  Karimi Shah, Banu A ^a   Chowdhury, Badrul A ^a  

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

Author keywords

[No Author keywords available]

Indexed keywords

NINTEDANIB; PIRFENIDONE; PLACEBO; ENZYME INHIBITOR; INDOLE DERIVATIVE; NONSTEROID ANTIINFLAMMATORY AGENT; PYRIDONE DERIVATIVE;

ANTIINFLAMMATORY ACTIVITY; CONTROLLED CLINICAL TRIAL (TOPIC); DISEASE EXACERBATION; DRUG APPROVAL; DRUG EFFICACY; DRUG MARKETING; DRUG MECHANISM; DRUG SAFETY; FIBROSING ALVEOLITIS; FOOD AND DRUG ADMINISTRATION; FORCED VITAL CAPACITY; HUMAN; LUNG TRANSPLANTATION; MORTALITY; OUTCOME ASSESSMENT; PRIORITY JOURNAL; REVIEW; RISK BENEFIT ANALYSIS; STUDY DESIGN; TREATMENT DURATION; ADVISORY COMMITTEE; CAUSE OF DEATH; DRUG EFFECTS; IDIOPATHIC PULMONARY FIBROSIS; PATHOPHYSIOLOGY; UNITED STATES; VITAL CAPACITY;

ADVISORY COMMITTEES; ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; CAUSE OF DEATH; DRUG APPROVAL; ENZYME INHIBITORS; HUMANS; IDIOPATHIC PULMONARY FIBROSIS; INDOLES; PYRIDONES; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; VITAL CAPACITY;

EID: 84925427675     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMp1500526     Document Type: Article

References (4)

1. Food and Drug Administration. Drugs@FDA: FDA approved drug products (http://www.accessdata.fda.gov/scripts/cder/drugsatfda).
2. Karimi-Shah BA. Pulmonary-Allergy Drugs Advisory Committee meeting: pirfenidone capsules NDA 22-535, S-000. Silver Spring, MD: Food and Drug Administration, March 9, 2010 (http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PulmonaryAllergyDrugsAdvisoryCommittee/UCM206398.pdf).
3. Raghu G, Collard HR, Anstrom KJ, et al. Idiopathic pulmonary fibrosis: clinically meaningful primary endpoints in phase 3 clinical trials. Am J Respir Crit Care Med 2012;185:1044-8.
4. Collard HR, King TE Jr, Bartelson BB, Vourlekis JS, Schwarz MI, Brown KK. Changes in clinical and physiologic variables predict survival in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med 2003;168:538-42.