10.6084/m9.figshare.9794933.v1
Susan J. Keam
Susan J.
Keam
Pretomanid: First Approval
Adis Journals
2019
Pretomanid
TB
XDR TB
MDR TB
Review
Adis Insight Report
2019-10-04 00:23:17
Online resource
https://adisjournals.figshare.com/articles/online_resource/Pretomanid_First_Approval/9794933
<div><b>Compliance with Ethical Standards</b></div><div><br></div><div><i>Funding</i>: The preparation of this review was not supported by any external funding.</div><div><br></div><div><i>Conflicts of interest:</i> During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Susan Keam is a salaried employee of Adis International Ltd/Springer Nature, is responsible for the article content and declares no relevant conflicts of interest</div><div><br></div><div>Additional
information about this Adis Drug Review can be found <b><a href="http://www.springer.com/gp/adis/products-services/adis-journals-newsletters/adis-drug-reviews">here</a></b><br></div><div><br></div><div>Abstract</div><div><br></div><div><p>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 extensively
drug-resistant (XDR) TB and 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.</p></div><div><br></div><div>© Springer Nature
Switzerland AG 2019<br></div><div><br></div>