New Regimen Including Pretomanid Receives Market Authorization in EU for XDR-TB

11 Aug 2020
by Working Group

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 or non-responsive MDR-TB. TB Alliance made an announcement on August 3rd that the three-drug regimen provides a new treatment option for patients in the European Union. The novel compound was approved in India by the DCGI under the same conditions last month. Last year, Pretomanid was approved by the United States FDA when used in this regimen for this same indication. 

Pretomanid is a member of the compound class nitroimidazooxazines. It has been under development by TB Alliance since 2002. These approvals have come after the publishing on the TB Alliance sponsored clinical trial Nix-TB

For more information on the EC conditional marketing authorization for pretomanid, please visit the TB Alliance website here

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. Center 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,...
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...