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

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