Pretomanid: First Approval

Pretomanid, an oral nitroimidazooxazine antimycobacterial agent administered as part of the BPaL (bedaquiline, pretomanid and linezolid) and BPaMZ (bedaquiline, pretomanid, moxifloxacin and pyrazinamide) regimens, has been developed by the Global Alliance for TB Drug Development (TB Alliance) under...

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Bibliographic Details
Published in:Drugs (New York, N.Y.) N.Y.), 2019-11, Vol.79 (16), p.1797-1803
Main Author: Keam, Susan J.
Format: Article
Language:English
Subjects:
AdisInsight Report
Agreements
Alliances
Anti-Bacterial Agents - administration & dosage
Anti-Bacterial Agents - therapeutic use
Antifungal Agents - administration & dosage
Antifungal Agents - therapeutic use
Drug Approval
Drug development
Fungicides
Humans
Income
Internal Medicine
Licensing
Linezolid
Medicine
Medicine & Public Health
Moxifloxacin
Multidrug resistance
Nitroimidazoles - administration & dosage
Nitroimidazoles - therapeutic use
Pharmacology/Toxicology
Pharmacotherapy
Pyrazinamide
Tuberculosis
Tuberculosis - drug therapy
United States
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Summary:Pretomanid, an oral nitroimidazooxazine antimycobacterial agent administered as part of the BPaL (bedaquiline, pretomanid and linezolid) and BPaMZ (bedaquiline, pretomanid, moxifloxacin and pyrazinamide) regimens, has been developed by the Global Alliance for TB Drug Development (TB Alliance) under license from Novartis, for the treatment for tuberculosis (TB). TB Alliance has licensed Mylan to manufacture and commercialize pretomanid for use as part of the BPaMZ and BPaL regimens. The license is non-exclusive in low- and middle-income countries and exclusive in high-income markets. Pretomanid, as part of the BPaL regimen, was recently approved in the USA under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) pathway for the treatment of adults with pulmonary extensively drug-resistant (XDR) or treatment-intolerant or non-responsive multidrug-resistant (MDR) TB. Pretomanid is also under regulatory review in the EU. This article summarizes the milestones in the development of pretomanid leading to this first regulatory approval.
ISSN:0012-6667
1179-1950
DOI:10.1007/s40265-019-01207-9