News

FDA Hosts Antimicrobial Drug Advisory Committee Meeting to Discuss NDA for Tuberculosis

**Update: The US FDA Antimicrobial Drug Advisory Committee voted in favor of the NDA 14 to 4 on June 6th, 2019**

The United States Food & Drug Administration (FDA) will host the Antimicrobial Drug Advisory Committee on Thursday, June 6th to discuss the new drug application (NDA) involving new chemical entity, pretomanid, in combination with bedaquiline and linezolid in an all-oral 6-month defined regimen for adults with extensively drug resistant (XDR) tuberculosis or treatment-intolerant or non-responsive multidrug resistant (MDR) tuberculosis submitted by TB Alliance. 

The FDA will provide a live web broadcast of the meeting which will take place from 8AM to 4PM. A link to the broadcast can be found here: webcast.

A link to the agenda of the meeting can be found here: June 6th, 2019 Antimicrobial Drug Advisory Committee Meeting Agenda.

Further materials relating to the NDA and meeting can be found here: meeting materials.

For more information about Pretomanid, please visit the WGND compound page on Pretomanid where you can view links to clinical trials and regimens involving Pretomanid. 

Additional links: 

TB Alliance's Press Release

Reuters article

More News
10 Dec 2020
The Stop TB Partnership Working Group on New TB Vaccines (WGNV), Working Group on New TB Drugs (WGND), and New Diagnostics Working Group (NDWG) are developing an online course specifically designed for advocates and affected communities to provide a base of knowledge in TB research and to generate...
22 Oct 2020
On Thursday, October 21st, 2020, the U.S. Centers for Disease Control and Prevention's (CDC) TB Trials Consortium (TBTC) announced results from their Phase 3, open-label trial: Study 31/A5349. The clinical trial identified a 4-month drug regimen composed of high-dose rifapentine, moxyifloxacin,...
11 Aug 2020
The European Commission (EC) has provided conditional marketing authorization for pretomanid, a novel compound developed by TB Alliance, when used in combination with bedaquiline and linezolid as part of a six month, all-oral regimen for the treatment of adults with XDR-TB or treatment-intolerant...