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
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...
29 Jul 2020
The WGND is announcing a call for applications to become a part of the WGND Core Group (CG). The CG provides leadership and sets the strategic direction for the work of the WGND. Addmitted applicants will begin their term in September 2020. Current CG membership information is available on the WGND...
9 Jul 2020
Earlier this week, Johnson & Johnson announced a reduction in the price for bedaquiline in low- and middle-income countries, as part of a collaboration with the Stop TB Partnership's Global Drug Facility (GDF). The immediate change in price will make bedaquiline available through the GDF at the...