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
21 Mar 2019
On December 6, 2018, at 7AM EST, TREAT TB will host a capacity building webinar on community engagement in MDR-TB clinical trials. It will feature a presentation from Ezio Tavora dos Santos Filho, STREAM Community Engagement Coordinator from REDE-TB , followed by a question and answer session. The...
12 Mar 2019
On March 8th, TB Alliance announced its novel compound, Pretomanid, is currently being reviewed by the FDA for use against Tuberculosis. TB Alliance's press release can be found below: NEW YORK, NY (March 8, 2019)—TB Alliance’s new drug application (NDA) for the novel tuberculosis (TB) drug...
29 Nov 2018
On December 6, 2018, at 7AM EST, TREAT TB will host a capacity building webinar on community engagement in MDR-TB clinical trials. It will feature a presentation from Ezio Tavora dos Santos Filho, STREAM Community Engagement Coordinator from REDE-TB , followed by a question and answer session. The...